AccessGUDID - DEVICE: Osteotec Silicone Finger Implant

GUDID

Device Identifier (DI) Information

Brand Name: Osteotec Silicone Finger Implant - Size 2
Version or Model: OSTF-2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OSTF-2
Company Name: OSTEOTEC LIMITED

Primary DI Number: 05060183090033
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 348489386 *Terms of Use

Device Description: The Osteotec Silicone Finger Implant (uncemented) is a one-piece, flexible silicone elastomer implant which is placed in the proximal and distal intramedullary canals of either metacarpophalangeal (MCP) or proximal interphalangeal (PIP) finger joints during resection arthroplasty.

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?
64460	Metacarpophalangeal/proximal interphalangeal joint prosthesis	An implantable device designed as a joint artificial substitute that may be used for both the metacarpophalangeal (MCP) and the proximal interphalangeal (PIP) joints of the hand (finger) [i.e. it is not dedicated to either joint], typically to treat cases of joint damage caused by rheumatoid, degenerative, or traumatic arthritis. It consists of a single flexible across-the-joint component (one-piece) made from synthetic polymer materials [e.g., a silicone elastomer].	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KYJ	Prosthesis, Finger, Constrained, Polymer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140453	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
No Device Sizes

Device Record Status

Public Device Record Key: 9c5f1244-528c-41c7-9766-8c5f85824ecc
Public Version Date: January 17, 2025
Public Version Number: 2
DI Record Publish Date: February 04, 2022