AccessGUDID - DEVICE: Miltex® (10381780038443)

GUDID

Device Identifier (DI) Information

Brand Name: Miltex®
Version or Model: 62511
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 62511
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780038443
Issuing Agency: GS1
Commercial Distribution End Date: December 22, 2016
Device Count: 12
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: 27" SZ 3-0 VIOLT PGA ABS C-6 NEEDLE CIR REV CUT

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?
13908	Polyglycolic acid suture	A sterile, typically multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) that is 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; it may be coated with a material such as polycaprolactone or uncoated. 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 [?]
K033762	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
Device Size Text, specify: 27" Size 3-0

Device Record Status

Public Device Record Key: 137aeb4c-29c1-40f4-99da-bea0cfee9161
Public Version Date: February 05, 2020
Public Version Number: 4
DI Record Publish Date: September 22, 2015