Identity
- Trade Name
- FMS FDA UDI
- Generic Name
- Surgical drill guide obturator FDA UDI
- Device Name
- FMS INFLOW/OUTFLOW SHEATH Obturator Inflow/Outflow-Wolf FDA UDI
- Model / Reference
- 283590 FDA UDI
- Description
- FMS INFLOW/OUTFLOW SHEATH Obturator Inflow/Outflow-Wolf FDA UDI
Identifiers
- Catalog Number
- 283590 FDA UDI
- Primary DI / UDI-DI
- 10886705023660 FDA UDI
- FDA Product Code
- NBH FDA UDI
- GMDN Term
- Surgical drill guide obturator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.1100 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
Yes
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
Fms by DePuy Mitek, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- DePuy Mitek, Inc.
Sources (1)
- FDA UDI 77470cfe-2ec7-4074-a9ea-4182382345fd 36 fields · synced May 30, 2026