Identity
- Trade Name
- De Soutter Medical FDA UDI
- Generic Name
- Bone/joint surgical power tool motorized handpiece/set, electric, reusable FDA UDI
- Device Name
- MCI-280 OSTEODRIVE HANDPIECE - STRAIGHT CASE (35k) FDA UDI
- Model / Reference
- 1294664 FDA UDI
- Description
- MCI-280 OSTEODRIVE HANDPIECE - STRAIGHT CASE (35k) FDA UDI
Identifiers
- Catalog Number
- 1294664 FDA UDI
- Primary DI / UDI-DI
- 05051471197633 FDA UDI
- FDA Product Code
- GEY FDA UDI
- GMDN Term
- Bone/joint surgical power tool motorized handpiece/set, electric, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone/joint surgical power tool motorized handpiece/set, electric, reusable
De Soutter Medical by De Soutter Medical, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- De Soutter Medical, Ltd.
Sources (1)
- FDA UDI 457dd2c7-a519-4f14-920c-76b1cc95d170 34 fields · synced May 29, 2026