Identity
- Trade Name
- OsteoMed FDA UDI
- Generic Name
- Medullary canal orthopaedic reamer, rigid FDA UDI
- Device Name
- 18mm Circular Metatarsal Reamer FDA UDI
- Model / Reference
- 323-2418 FDA UDI
- Description
- 18mm Circular Metatarsal Reamer FDA UDI
Identifiers
- Catalog Number
- 323-2418 FDA UDI
- Primary DI / UDI-DI
- 00842528123256 FDA UDI
- FDA Product Code
- HTO FDA UDI
- GMDN Term
- Medullary canal orthopaedic reamer, rigid 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 0.772 Inch FDA UDI
Category: Medullary canal orthopaedic reamer, rigid
OsteoMed by Osteomed Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Medullary canal orthopaedic reamer, rigid.
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- INSTRUMENT — Howmedica Osteonics Corp. · 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
- Osteomed Corp.
Sources (1)
- FDA UDI 1619c4ec-0337-4da8-970c-58ea0e4686f8 37 fields · synced Jun 1, 2026