Identity
- Trade Name
- FMS FDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Device Name
- FMS INFLOW/OUTFLOW SHEATH KIT Inflow/Outflow Sheath-Stryker FDA UDI
- Model / Reference
- 218021 FDA UDI
- Description
- FMS INFLOW/OUTFLOW SHEATH KIT Inflow/Outflow Sheath-Stryker FDA UDI
Identifiers
- Catalog Number
- 218021 FDA UDI
- Primary DI / UDI-DI
- 10886705023745 FDA UDI
- FDA Product Code
- NBH FDA UDI
- GMDN Term
- Endoscope sheath, reusable 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 194c34b9-fa02-4027-983d-7ce70965ab1e 36 fields · synced May 31, 2026