Identity
- Trade Name
- Cook FDA UDI
- Generic Name
- Endomyocardial biopsy forceps, single-use FDA UDI
- Device Name
- Cook Flexible Biopsy Forceps FDA UDI
- Model / Reference
- G05389 FDA UDI
- Description
- Cook Flexible Biopsy Forceps FDA UDI
Identifiers
- Catalog Number
- FBF-5.2-120 FDA UDI
- Primary DI / UDI-DI
- 00827002053892 FDA UDI
- FDA Product Code
- DWZ FDA UDI
- GMDN Term
- Endomyocardial biopsy forceps, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4075 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: Endomyocardial biopsy forceps, single-use
Cook by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endomyocardial biopsy forceps, single-use.
- Biopsy Forceps — Cordis US Corp. · Class II
- Jawz Endomyocardial Biopsy Forceps — Argon Medical Devices, Inc. · Class II
- Jawz Endomyocardial Biopsy Forceps — Argon Medical Devices, Inc. · Class II
- Jawz Endomyocardial Biopsy Forceps — Argon Medical Devices, Inc. · Class II
- SparrowHawk — ATC TECHNOLOGIES INC. · Class II
- BIPAL — Cordis US Corp. · Class II
- Procure™ — ST. JUDE MEDICAL, INC. · Class II
- Jawz Endomyocardial Biopsy Forceps — Argon Medical Devices, 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 Incorporated
Sources (1)
- FDA UDI 1f37c0c9-deba-4fdf-bfab-9ab992658584 36 fields · synced Jun 8, 2026