Identity
- Trade Name
- Zinnanti Surgical FDA UDI
- Generic Name
- Open-surgery biopsy forceps, reusable FDA UDI
- Device Name
- J-Tip Biopsy Cartridge FDA UDI
- Model / Reference
- 14-4005J FDA UDI
- Description
- J-Tip Biopsy Cartridge FDA UDI
Identifiers
- Primary DI / UDI-DI
- G373144005J0 FDA UDI
- 510(k) Number
- K892252 FDA UDI
- FDA Product Code
- FCL FDA UDI
- GMDN Term
- Open-surgery biopsy forceps, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Open-surgery biopsy forceps, reusable
Zinnanti Surgical by Zinnanti Surgical Design Group Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Zinnanti Surgical Design Group Inc
Sources (1)
- FDA UDI 8ef14dd7-886b-47fb-bf9f-eade5eb56335 34 fields · synced Jun 8, 2026