FDA UDI
In Commercial Distribution
🇺🇸 United States
Osteotec Silicone Finger Implant - Size 00
DI: 05060183090002
·
Model: OSTF-00
·
OSTEOTEC LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Osteotec Silicone Finger Implant - Size 00
- Primary DI
- 05060183090002
- Version / Model
- OSTF-00
- Catalog Number
- OSTF-00
- Company Name
- OSTEOTEC LIMITED
- Labeler DUNS
- 348489386
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-04
- Public Version
- 1
- Public Version Date
- 2022-02-14
- Public Version Status
- New
- Public Device Record Key
- 62986f9c-7c48-4e11-be42-c09293e44fac
Device Description
The Osteotec Silicone Finger Implant 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
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KYJ | Prosthesis, Finger, Constrained, Polymer | Orthopedic | 888.3230 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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]. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060183090002 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K140453 | 000 |