Identity
- Trade Name
- ELAN 4 FDA UDI
- Generic Name
- Bone/joint surgical power tool motorized handpiece/set, electric, reusable FDA UDI
- Device Name
- ELAN 4 2-RING DISP.WIRE PASS DRILL D1.0 FDA UDI
- Model / Reference
- US828SU FDA UDI
- Description
- ELAN 4 2-RING DISP.WIRE PASS DRILL D1.0 FDA UDI
Identifiers
- Catalog Number
- US828SU FDA UDI
- Primary DI / UDI-DI
- 04046955212149 FDA UDI
- FDA Product Code
- HBE FDA UDI
- GMDN Term
- Bone/joint surgical power tool motorized handpiece/set, electric, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4310 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Elan 4 by Aesculap, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Aesculap, Inc.
Sources (1)
- FDA UDI 36ce00df-077c-4ac9-825d-d8cafe564304 36 fields · synced May 31, 2026