AccessGUDID - DEVICE: Miltex® (10381780038467)

GUDID

Device Identifier (DI) Information

Brand Name: Miltex®
Version or Model: 62509
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 62509
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780038467
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: 18" SZ4-0 SLK BLK NON-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?
13910	Silk suture	A natural, non-bioabsorbable thread made from raw silk spun by silkworms (typically coated with beeswax or silicone) 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. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a "non-bioabsorbable" material, it may be digested by proteolysis after an extended period of time. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GAP	SUTURE, NONABSORBABLE, SILK

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K020901	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: 18" Size 4-0

Device Record Status

Public Device Record Key: cabf848c-f9c1-4bd3-8e13-28d654f37861
Public Version Date: February 05, 2021
Public Version Number: 5
DI Record Publish Date: September 22, 2015