Identity
- Trade Name
- STERIS FDA UDI
- Generic Name
- Surgical plume evacuation system tube FDA UDI
- Device Name
- ICM-000-0649 STERIS ESU Shroud, Short Tip, 9 Foot Tube & 22 mm to 10 mm Connector, Non-Sterile, Bulk FDA UDI
- Model / Reference
- SSESHR03 FDA UDI
- Description
- ICM-000-0649 STERIS ESU Shroud, Short Tip, 9 Foot Tube & 22 mm to 10 mm Connector, Non-Sterile, Bulk FDA UDI
Identifiers
- Catalog Number
- SSESHR03 FDA UDI
- Primary DI / UDI-DI
- 00817688023586 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Surgical plume evacuation system tube FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Ethylene Oxide FDA UDI
Steris by I.C. Medical, 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 |
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Manufacturer
- Manufacturer
- I.C. Medical, Inc.
Sources (1)
- FDA UDI a74603cd-dd5b-48c0-b116-128372bb3fb9 37 fields · synced May 31, 2026