Identity
- Trade Name
- Removal Tool, 3.5mm FDA UDI
- Generic Name
- Orthopaedic implant reamer FDA UDI
- Device Name
- Orthopaedic implant reamer FDA UDI
- Model / Reference
- EZO 135 FDA UDI
- Description
- Orthopaedic implant reamer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840118118378 FDA UDI
- FDA Product Code
- LXH 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 200 Millimeter FDA UDIOuter Diameter — 3.5 Millimeter FDA UDI
Category: Orthopaedic implant reamer
Removal Tool, 3.5mm by Flower Orthopedics Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic implant reamer.
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- FPS — Tyber Medical · Class I
- LEOS — Tyber Medical · Class I
- LEOS — Tyber Medical · Class I
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class I
- LEOS — 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
- Flower Orthopedics Corporation
Sources (1)
- FDA UDI fe6029db-22d7-4561-99eb-401f40828f46 35 fields · synced May 30, 2026