AccessGUDID - DEVICE: Safil (04046963671679)

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Device Identifier (DI) Information

Brand Name: Safil
Version or Model: C1048987
Catalog Number: C1048987
Company Name: B BRAUN SURGICAL SA

Primary DI Number: 04046963671679
Issuing Agency: GS1
Device Count: 36

Device Description: SAFIL VIOLET 0 (3.5) 90CM HRB40S (M)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Polyglycolic acid suture	A sterile, single-strand (monofilament), synthetic, bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) that is intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. It may include an attached needle intended to be disposed of after single use; it may be coated with a material such as polycaprolactone or uncoated. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Polyglycolic acid suture

A sterile, single-strand (monofilament), synthetic, bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) that is intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. It may include an attached needle intended to be disposed of after single use; it may be coated with a material such as polycaprolactone or uncoated. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
GAM	SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Size of Thread (USP - Others) : 0
Length: 90.00 Centimeter
Device Size Text, specify: Thread Material : polyglycolic acid

Device Status

Commercial Distribution Status: Not in Commercial Distribution
DI Record Publish Date: August 17, 2015
Commercial Distribution End Date: August 21, 2015