AccessGUDID - DEVICE: Monomax (04046964028311)

GUDID

Device Identifier (DI) Information

Brand Name: Monomax
Version or Model: C9972003
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: C9972003
Company Name: B BRAUN SURGICAL SA

Primary DI Number: 04046964028311
Issuing Agency: GS1
Commercial Distribution End Date: October 25, 2018
Device Count: 36
Labeler D-U-N-S® Number*: 511268005 *Terms of Use

Device Description: MONOMAX UNDY 5/0(1)45CM DSMP16USA40%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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
16584	Polyester suture, bioabsorbable, monofilament, non-antimicrobial	A single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester (e.g., polydioxanone, poliglecaprone, polycaprolactone, polyglyconate, polyhydroxybutyrate) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.	Active	true

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: Size of Thread (USP - Others) : 5/0
Device Size Text, specify: Thread Material : polyhydroxibutyrate
Length: 45.00 Centimeter

Device Record Status

Public Device Record Key: 57bf5c31-9fef-40ce-bb64-738a4827c5c2
Public Version Date: February 05, 2021
Public Version Number: 8
DI Record Publish Date: August 19, 2015