Identity
- Trade Name
- ORTHOMED FDA UDI
- Generic Name
- Medullary canal orthopaedic reamer, flexible FDA UDI
- Device Name
- MEDULLARY REAMER, FLEXIBLE 11.0MM X 480MM SHARP HEAD, HUDSON-COUPLING CANNULATED 3.5MM FDA UDI
- Model / Reference
- OM R27440S-110 FDA UDI
- Description
- MEDULLARY REAMER, FLEXIBLE 11.0MM X 480MM SHARP HEAD, HUDSON-COUPLING CANNULATED 3.5MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- B803R27440S1100 FDA UDI
- FDA Product Code
- HTO FDA UDI
- GMDN Term
- Medullary canal orthopaedic reamer, flexible 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
No
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: Medullary canal orthopaedic reamer, flexible
Orthomed by Ortho-Med, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medullary canal orthopaedic reamer, flexible.
- MODULAR FLEXIBLE REAMER HEAD, Ø10.0mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- Patella Inlay Reamer Size 5 — SIGNATURE ORTHOPAEDICS PTY LTD · Class I
- ARCOS MODULAR REVISION SYSTEM — Biomet Orthopedics, Inc. · Class II
- ARCOS MODULAR REVISION SYSTEM — Biomet Orthopedics, Inc. · Class II
- Arthrex® — Arthrex, Inc. · Class I
- NITINOL MODULAR REAMER HUDSON — Biomet Orthopedics, Inc. · Class I
- Dyna Locking IM Nail — CG MedTech Co., Ltd. · Class I
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ortho-Med, Inc.
Sources (1)
- FDA UDI d0181b2a-828e-40c4-851f-ccdafdb41906 33 fields · synced Jun 8, 2026