Identity
- Trade Name
- Cook FDA UDI
- Generic Name
- Endoscopic stent-placement system FDA UDI
- Device Name
- Stent Introducer Set FDA UDI
- Model / Reference
- G22684 FDA UDI
- Description
- Stent Introducer Set FDA UDI
Identifiers
- Catalog Number
- SIS-10 FDA UDI
- Primary DI / UDI-DI
- 00827002226845 FDA UDI
- FDA Product Code
- FGE FDA UDI
- GMDN Term
- Endoscopic stent-placement system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscopic stent-placement system
Cook by Cook Ireland, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic stent-placement system.
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- Single Use Stent Insertion Kit V — Olympus Medical Systems Corporation · Class I
- NaviFlex™ RX Pusher — Boston Scientific · Class II
- NaviFlex™ RX Delivery System — Boston Scientific · Class II
- Hobbs Pusher Catheter — HOBBS MEDICAL, INC. · Class II
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
- Cook Ireland, Ltd.
Sources (1)
- FDA UDI b9ea08af-99c8-45eb-be94-cfe1545cb8f4 36 fields · synced Jun 1, 2026