AccessGUDID - DEVICE: Integra® Miltex® (10381780426905)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Miltex®
Version or Model: 27-458C
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 27-458C
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780426905
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Miltex® Hibbs Gouge, 9-3/4", Curved, 1/4" Wide

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:	No
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?
35090	Surgical gouge	A heavy-duty, hand-held, surgical instrument used to remove pieces of bone or other hard tissue during orthopaedic and plastic surgery procedures. It typically comprises a handle proximally which becomes a shaft that terminates in a convex profile with a sharp, semi-lunar, bevelled cutting edge to facilitate tissue removal. It is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. It is typically made of high-grade stainless steel and can be designed as a one-piece instrument (all steel) or the handle may be made of synthetic material (e.g., Tufnol). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDH	GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 1/4" Wide
Device Size Text, specify: 9-3/4"

Device Record Status

Public Device Record Key: ba0dc3c0-4022-47aa-8aa0-e82a9c7b2973
Public Version Date: April 27, 2023
Public Version Number: 5
DI Record Publish Date: January 10, 2018