AccessGUDID - DEVICE: MONOCRYL (10705031046856)

GUDID

Device Identifier (DI) Information

Brand Name: MONOCRYL
Version or Model: MCPB345H
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MCPB345H
Company Name: ETHICON, LLC

Primary DI Number: 10705031046856
Issuing Agency: GS1
Commercial Distribution End Date: September 11, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 079402290 *Terms of Use

Device Description: Antibacterial Violet Monofilament (Poliglecaprone 25), Absorbable Surgical Suture

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:	Yes
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?
46317	Poliglecaprone suture, antimicrobial	A sterile, single-strand (monofilament), synthetic, bioabsorbable thread made of poliglecaprone (a copolymer of glycolide and E-caprolactone of low tissue reactivity) and containing an agent to locally inhibit bacterial growth, 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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GAM	SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K050845	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6500a3d0-3fa4-4139-ac7d-22489db0f319
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 01, 2015