Identity
- Trade Name
- INSTRUMENT FDA UDI
- Generic Name
- Acetabular orthopaedic reamer FDA UDI
- Device Name
- SPECIALTY TRIDENT ACETABULAR HIGH RIM REAMER FDA UDI
- Model / Reference
- I-H0659HA75 FDA UDI
- Description
- SPECIALTY TRIDENT ACETABULAR HIGH RIM REAMER FDA UDI
Identifiers
- Catalog Number
- I-H0659HA75 FDA UDI
- Primary DI / UDI-DI
- 07613327320558 FDA UDI
- FDA Product Code
- JDI FDA UDILPH FDA UDIKWZ FDA UDILWJ FDA UDIMAY FDA UDIKWL FDA UDILZO FDA UDIMBL FDA UDIHWC FDA UDIMEH FDA UDIKWY FDA UDI
- GMDN Term
- Acetabular orthopaedic reamer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3350 FDA UDI888.3358 FDA UDI888.3310 FDA UDI888.3360 FDA UDI888.3353 FDA UDI888.3040 FDA UDI888.3390 FDA UDI
- Commercial Distribution
- Not 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
No
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
Instrument by Howmedica Osteonics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Howmedica Osteonics Corp.
Sources (1)
- FDA UDI 3f947f76-54c1-4d0e-b566-bf815ea2589d 36 fields · synced May 31, 2026