AccessGUDID - DEVICE: Monomax (04046963989316)

GUDID

Device Identifier (DI) Information

Brand Name: Monomax
Version or Model: B9941120
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: B9941120
Company Name: B BRAUN SURGICAL SA

Primary DI Number: 04046963989316
Issuing Agency: GS1
Commercial Distribution End Date: February 24, 2016
Device Count: 24
Labeler D-U-N-S® Number*: 511268005 *Terms of Use

Device Description: MONOMAX VLT 1(4)150CM HR65 USA LOOP(MDDP

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
Polybutester suture	A sterile, single-strand (monofilament), synthetic, non-bioabsorbable thread made of polybutester, a copolymer of polyglycol terephthalate and polytrimethylene terephthalate, 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. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is very elastic and has a low coefficient of friction, making it ideal for surface closure, and does not lose tensile strength or become absorbed. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Polybutester suture

A sterile, single-strand (monofilament), synthetic, non-bioabsorbable thread made of polybutester, a copolymer of polyglycol terephthalate and polytrimethylene terephthalate, 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. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is very elastic and has a low coefficient of friction, making it ideal for surface closure, and does not lose tensile strength or become absorbed. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
NWJ	Suture, recombinant technology

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

[?]

Storage and Handling
Storage Environment Temperature: between 0 and 50 Degrees Celsius

Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Thread Material : polyhydroxibutyrate
Device Size Text, specify: Size of Thread (USP - Others) : 1
Length: 150.00 Centimeter

Device Record Status

Public Device Record Key: a7f4d831-bc22-4989-a95d-cda2d27012b3
Public Version Date: June 21, 2018
Public Version Number: 3
DI Record Publish Date: November 01, 2015