AccessGUDID - DEVICE: Integra® (10381780257721)

GUDID

Device Identifier (DI) Information

Brand Name: Integra®
Version or Model: FGT-40T
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780257721
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 942377524 *Terms of Use
Previous DI: 00846832006601

Device Description: FGT Implant Size 40 The Integra® Primus Flexible Great Toe (model FGT) is a third generation implant for supplementation of first metatarsophalangeal joint arthroplasty. The implant is constructed from medical grade silicone elastomer and includes titanium grommets.

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?
33700	Total metatarsophalangeal joint prosthesis, one-piece	An implantable device designed to replace the metatarsophalangeal (MTP) joint(s) of the foot (toe). The device is made of a single piece of silicone elastomer. It is is intended to treat degenerative or traumatic arthritis, hallux valgus, hallus rigidus, and/or an unstable or painful MTP joint.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWH	PROSTHESIS, TOE, CONSTRAINED, POLYMER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K981194	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: 40

Device Record Status

Public Device Record Key: 389ac5e1-8bb9-459f-ab51-2f8d0e5c0e98
Public Version Date: January 25, 2023
Public Version Number: 6
DI Record Publish Date: July 25, 2016