AccessGUDID - DEVICE: OPTILENE (04046964796494)

GUDID

Device Identifier (DI) Information

Brand Name: OPTILENE
Version or Model: G3090758
Commercial Distribution Status: In Commercial Distribution
Catalog Number: G3090758
Company Name: B BRAUN SURGICAL SA

Primary DI Number: 04046964796494
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 511268005 *Terms of Use

Device Description: OPTILENE 8/0(0,4)60CM 2XDRM8 140MIC RCP

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
Polyolefin suture, monofilament	A single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene, polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., 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. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device intended to be used in a sterile condition.

GMDN Preferred Term Name

GMDN Definition

Polyolefin suture, monofilament

A single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene, polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., 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. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device intended to be used in a sterile condition.

FDA Product Code

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Product Code	Product Code Name
GAW	SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

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
Length: 60.0 Centimeter
Device Size Text, specify: Thread Material : polypropylene with polyethylen
Device Size Text, specify: Size of Thread (USP - Others) : 8/0

Device Record Status

Public Device Record Key: aab4066c-46a6-44c9-bd7f-76e7a19ca0e8
Public Version Date: February 07, 2019
Public Version Number: 3
DI Record Publish Date: December 11, 2016