Identity
- Trade Name
- Conformis Hip System FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- ITOTAL HIP INSTRUMENT CASE, REAMERS FDA UDI
- Model / Reference
- 1080-115 FDA UDI
- Description
- ITOTAL HIP INSTRUMENT CASE, REAMERS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850268007880 FDA UDI
- FDA Product Code
- OQG FDA UDIMEH FDA UDILZO FDA UDILPH FDA UDI
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 FDA UDI888.3353 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
Conformis Hip System by Conformis, Inc. — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Conformis, Inc.
Sources (1)
- FDA UDI c369ef4b-4fa6-4fa3-b3f6-dc9b0e429e6c 35 fields · synced May 30, 2026