AccessGUDID - DEVICE: Monomax (04046963989378)

GUDID

Device Identifier (DI) Information

Brand Name: Monomax
Version or Model: B9941123
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: B9941123
Company Name: B BRAUN SURGICAL SA

Primary DI Number: 04046963989378
Issuing Agency: GS1
Commercial Distribution End Date: September 14, 2018
Device Count: 24
Labeler D-U-N-S® Number*: 511268005 *Terms of Use

Device Description: MONOMAX VLT 1(4)150CM HR76 USA 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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
17245	Polyester suture, non-bioabsorbable, monofilament	A single-strand (monofilament), synthetic thread made from a non-bioabsorbable polyester (e.g., polybutester) 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 disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently. 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) : 1
Device Size Text, specify: Thread Material : polyhydroxibutyrate
Length: 150.00 Centimeter

Device Record Status

Public Device Record Key: c8816e84-6348-4815-bb4c-e6dbacd53c02
Public Version Date: February 05, 2021
Public Version Number: 7
DI Record Publish Date: November 01, 2015