Identity
- Trade Name
- DJO SURGICAL FDA UDI
- Generic Name
- Orthopaedic implant reamer FDA UDI
- Device Name
- Special, AltiVate Anatomic Cannulated Ream-Run Reamer, Sz 40 FDA UDI
- Model / Reference
- S-201093 FDA UDI
- Description
- Special, AltiVate Anatomic Cannulated Ream-Run Reamer, Sz 40 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190446270010 FDA UDI
- FDA Product Code
- HTO FDA UDI
- GMDN Term
- Orthopaedic implant reamer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
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: Orthopaedic implant reamer
Djo Surgical by Encore Medical, L.p. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic implant reamer.
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- LEOS — Tyber Medical · Class I
- FPS — Tyber Medical · Class I
- FPS — Tyber Medical · 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
- Encore Medical, L.p.
Sources (1)
- FDA UDI 809e4970-494f-4dc0-895e-21f5365f8c78 33 fields · synced May 31, 2026