AccessGUDID - DEVICE: MONOMAX (04046963489991)

GUDID

Device Identifier (DI) Information

Brand Name: MONOMAX
Version or Model: B0041077
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B0041077
Company Name: B BRAUN SURGICAL SA

Primary DI Number: 04046963489991
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 24
Labeler D-U-N-S® Number*: 511268005 *Terms of Use

Device Description: MONOMAX VIOLET 1(4)150CM HR40S LOOP(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

[?]

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

GMDN Preferred Term Name	GMDN Definition
Polyhydroxybutyrate suture	A sterile, single-strand (monofilament), synthetic, bioabsorbable thread derived from poly-4-hydroxybutyrate [a material isolated from prokaryotic cells using recombinant deoxyribonucleic acid (DNA) technology] 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, and is subsequently absorbed by hydrolysis. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Polyhydroxybutyrate suture

A sterile, single-strand (monofilament), synthetic, bioabsorbable thread derived from poly-4-hydroxybutyrate [a material isolated from prokaryotic cells using recombinant deoxyribonucleic acid (DNA) technology] 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, and is subsequently absorbed by hydrolysis. This is a single-use device.

FDA Product Code

[?]

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

[?]

Size Type Text
Device Size Text, specify: Thread Material : polyhydroxibutyrate
Device Size Text, specify: Size of Thread (USP - Others) : 1
Length: 150.0 Centimeter

Device Record Status

Public Device Record Key: b96e6949-c727-4de4-b447-908155d0a039
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: November 25, 2016