FDA UDI
In Commercial Distribution
🇺🇸 United States
Universal Tendon Spacer
DI: 03700751502132
·
Model: 0232-01-00
·
ASKORN MEDICAL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Universal Tendon Spacer
- Primary DI
- 03700751502132
- Version / Model
- 0232-01-00
- Company Name
- ASKORN MEDICAL
- Labeler DUNS
- 289183779
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-20
- Public Version
- 1
- Public Version Date
- 2025-04-28
- Public Version Status
- New
- Public Device Record Key
- 1309ef54-50b7-40b9-8b70-762462c36028
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 |
|---|---|---|---|---|
| HXA | Prosthesis, Tendon, Passive | Orthopedic | 888.3025 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35276 | Tendon sheath regeneration implant | A device intended to be implanted to temporarily aid growth of a new tendon sheath for tendon reconstruction. It is made of synthetic polymer (e.g., a silicone elastomer or polyester-reinforced silicone elastomer) and/or metal materials. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03700751502132 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243477 | 000 |