Identity
- Trade Name
- ELOS INSTRUMENTS FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- T-Handle Chuck FDA UDI
- Model / Reference
- SE201 FDA UDI
- Description
- T-Handle Chuck FDA UDI
Identifiers
- Catalog Number
- SE201 FDA UDI
- Primary DI / UDI-DI
- 08056693000492 FDA UDI
- 510(k) Number
- K201147 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Surgical instrument handle, non-torque-limiting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical instrument handle, non-torque-limiting
Elos Instruments by Intrauma Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K201147 also covers:
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Intrauma Spa
Sources (1)
- FDA UDI a1c61e8b-e6b5-4387-af47-3e7aa0a18688 35 fields · synced Jun 8, 2026