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Table of Contents:

  • The Name of The Medical Device
  • The Name and The Address of The Manufacturer
  • Product Content List
  • Intended Use of The Product
  • Contraindication for Use
  • Device Description
  • User Profile
  • Storage, Shelf Life and Handling Information
  • Precautions, Warnings, Measures to Be Taken and Limitations
  • Symbols and Explanations

The Name of the Medical Device

SYRINGE ACCESSORIES
The product is a sterile, single use device.

The Name and the Address of the Manufacturer

T-Biyoteknoloji Laboratuvar Estetik Medikal Kozmetik San. Tic. Ltd. Şti.
Tahtalı Mh. Değirmen Yolu Sk. (460) No:10, 16280 Nilüfer/BURSA
Phone: +90 224 246 8522
E-mail: info@tlab.com.tr

Product Content List

The content of the packaging is one of the following products:

  • SYRINGE STAND
  • LUER FEMALE CAP
  • LUER- LUER FEMALE ADAPTER

Intended Use of the Product

SYRINGE ACCESSORIES are intended to aid in safe and efficient syringe handling.

Contraindication for Use

Do not use the device, if it does not meet the requirement(s) for use in the intended procedure(s).

Device Description

SYRINGE ACCESSORIES are sterile single use devices allow for easy, convenient and safe syringe handling with an ergonomic, rounded shape and a double-ended luer lock connection to prevent the risk of leaking and possible contamination. SYRINGE ACCESSORIES can be used with commercially available syringes of various volumes from 1ml to 60ml with luer-lock connection. Luer connections are tested to ensure conformity to applicable standards. Non-toxic and non-pyrogenic, SYRINGE ACCESSORIES are supplied individually blister packed and sterile.

LUER FEMALE CAP provides secure and versatile sterile closure of syringes using both a male and female luer lock connection. LUER FEMALE CAP are microbiologically and structurally integrity tested to ensure when used during a centrifuge process, there no leak at high centrifugal force.

LUER- LUER FEMALE ADAPTER can be securely applied to the end of male luer lock syringes, facilitating rapid, contaminant-free transfer of fluids in a sterile working environment preventing the risk of leaking.

SYRINGE STAND supports the syringe barrel upright whilst not in use, with a design compatible with hexagon shaped LUER FEMALE CAP, providing easy access and convenient storage.

User Profile

This product should be used by physicians or physician-directed allied health care professionals with adequate training in the use of the device.

Storage, Product Life and Handling Information

  • SYRINGE ACCESSORIES are sterilized with Ethylene Oxide.
  • Do not expose to direct sunlight.
  • Store in a cool, dry place.
  • For shelf life, refer to the expiration date printed on labelling.
  • Store at temperatures between 5°C and 30°C.

Precautions, Warnings, Measures to be Taken and Limitations

  • Do not use sterile component of the product if package is opened or damaged.
  • Single use device, do not reuse.
  • The user should be thoroughly familiar with the equipment and the procedure prior to using this device.
  • Do not dispose of this product in the unsorted municipal waste stream.

Symbols and Explanations

European Medical Devices Regulation 2017/745
Notified Body: Szutest (2195)
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Manufacturer
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Date of Manufacture
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Use By Date
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Catalogue Number
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Batch Code
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Sterilized Using Ethylene Oxide
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Do Not Re-sterilize
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Do Not Reuse
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Do Not Use if Package is Damaged
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Keep Away from Sunlight
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Keep Dry
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Temperature Limit
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Operator's Manual; Operating Instructions
Dikkat
Caution

TF07.IFU.R01   |   Release Date: 11/03/2020   |   Revision Date: 02/11/2020