Identity
- Trade Name
- Kopans FDA UDI
- Generic Name
- Surgical instrument guard, single-use FDA UDI
- Device Name
- Disposable Kopans Spring Hook Support Cannula FDA UDI
- Model / Reference
- G04053 FDA UDI
- Description
- Disposable Kopans Spring Hook Support Cannula FDA UDI
Identifiers
- Catalog Number
- DKSC-22-9.0 FDA UDI
- Primary DI / UDI-DI
- 00827002040533 FDA UDI
- FDA Product Code
- MIJ FDA UDI
- GMDN Term
- Surgical instrument guard, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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: Surgical instrument guard, single-use
Kopans by Cook Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical instrument guard, single-use.
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- Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
- Steri-Pocket — Hanes Companies, Inc. · Class I
- MSI Precision Specialty Instruments — Med Saver, 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 625b16b7-f46f-4844-b466-f0f2a7c2a92f 36 fields · synced Jun 8, 2026