AccessGUDID - DEVICE: HAVEL'S (B070A77CH0)

GUDID

Device Identifier (DI) Information

Brand Name: HAVEL'S
Version or Model: SUT. 4-0 CHROMIC GUT 18"/DS-12
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A77CH
Company Name: Havel's Incorporated

Primary DI Number: B070A77CH0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 101497568 *Terms of Use

Device Description: SUTURE 4-0 CHROMIC GUT 18"/DS-12

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?
45025	Catgut suture, chromic	A single-strand (monofilament), natural, bioabsorbable thread composed mostly of collagen fibres derived from mammals (e.g., sheep or bovine intestines), impregnated with chromium salts to increase tensile strength and retard absorption, 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 heals to withstand normal stress, and is subsequently absorbed by enzymatic degradation. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GAL	Suture, Absorbable, Natural

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 36b2df30-73a9-46c9-b316-6a75d7961b60
Public Version Date: November 11, 2024
Public Version Number: 5
DI Record Publish Date: June 16, 2016