Identity
- Trade Name
- Tecomet FDA UDI
- Generic Name
- Hand-held surgical retractor, reusable FDA UDI
- Device Name
- GLENOID NECK RETRACTOR FDA UDI
- Model / Reference
- KMPR6563 FDA UDI
- Description
- GLENOID NECK RETRACTOR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841435104556 FDA UDI
- FDA Product Code
- HTE FDA UDI
- GMDN Term
- Hand-held surgical retractor, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Tecomet by Tecomet, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Tecomet, Inc
Sources (1)
- FDA UDI b43b7e3d-e121-4b03-93ee-385fc22a05ae 34 fields · synced Sep 18, 2026