Identity
- Trade Name
- Cope FDA UDI
- Generic Name
- Non-vascular catheter introduction set FDA UDI
- Device Name
- Cope Catheter Introduction System FDA UDI
- Model / Reference
- G08620 FDA UDI
- Description
- Cope Catheter Introduction System FDA UDI
Identifiers
- Catalog Number
- CWGE-100-NT FDA UDI
- Primary DI / UDI-DI
- 00827002086203 FDA UDI
- FDA Product Code
- KGZ FDA UDI
- GMDN Term
- Non-vascular catheter introduction set FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Non-vascular catheter introduction set
Cope by Cook Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Inrad — Inrad · Class II
- MAK-NV™ — Merit Medical Systems, Inc. · Class I
- Operative Cholangiogram Catheter (ORC-A-20) With Percutaneous Introducer Needle — FLEXBAR MACHINE CORP. · Class I
- MAK-NV™ — Merit Medical Systems, Inc. · Class I
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
- Cook Incorporated
Sources (1)
- FDA UDI aa4af302-d692-4b39-8659-f55df35ab026 36 fields · synced Jun 8, 2026