Identity
- Trade Name
- ELITE MEDICAL INSTRUMENTATION FDA UDI
- Generic Name
- Bone hook FDA UDI
- Device Name
- Retractor, Richardson Eastman, Double Ended, Small/Medium (Pair) FDA UDI
- Model / Reference
- EMI-BT470R FDA UDI
- Description
- Retractor, Richardson Eastman, Double Ended, Small/Medium (Pair) FDA UDI
Identifiers
- Catalog Number
- EMI-BT470R RETRACTOR FDA UDI
- Primary DI / UDI-DI
- G569EMIBT470R0 FDA UDI
- FDA Product Code
- EIG FDA UDI
- GMDN Term
- Bone hook FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone hook
Elite Medical Instrumentation by Elite Medical Instrumentation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- GELPI NEROMA RETRACTOR — SONTEC INSTRUMENTS, INC. · Class I
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
- Elite Medical Instrumentation
Sources (1)
- FDA UDI 3ec5ce1d-ad39-4a88-896d-095c29016780 34 fields · synced Jun 1, 2026