Identity
- Trade Name
- BIPAL FDA UDI
- Generic Name
- Endomyocardial biopsy forceps, single-use FDA UDI
- Device Name
- BF BIPAL 7F 50CM 2.2MM MP-TIP FDA UDI
- Model / Reference
- 502402M FDA UDI
- Description
- BF BIPAL 7F 50CM 2.2MM MP-TIP FDA UDI
Identifiers
- Catalog Number
- 502402M FDA UDI
- Primary DI / UDI-DI
- 20705032054963 FDA UDI
- 510(k) Number
- K933235 FDA UDI
- FDA Product Code
- DWE FDA UDI
- GMDN Term
- Endomyocardial biopsy forceps, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4390 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
No
FDA UDI
Category: Endomyocardial biopsy forceps, single-use
Bipal by Cordis Corp. — 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
Cleared under the same submission
K933235 also covers:
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
- Cordis Corp.
Sources (1)
- FDA UDI 25ceb703-89ca-462c-9214-6bc84b2d0071 36 fields · synced May 30, 2026