Identity
- Trade Name
- Zinnanti Surgical FDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- 6" Smoke Evac Fusion 12mm x 10mm Sail Loop FDA UDI
- Model / Reference
- 14-0120 FDA UDI
- Description
- 6" Smoke Evac Fusion 12mm x 10mm Sail Loop FDA UDI
Identifiers
- Primary DI / UDI-DI
- G3731401200 FDA UDI
- 510(k) Number
- K092634 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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: Open-surgery electrosurgical electrode, monopolar, single-use
Zinnanti Surgical by Zinnanti Surgical Design Group Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Open-surgery electrosurgical electrode, monopolar, single-use.
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Cleared under the same submission
K092634 also covers:
- Arms Medical — ZINNANTI SURGICAL DESIGN GROUP INC
- Diagnostic Medical — ZINNANTI SURGICAL DESIGN GROUP INC
- Diagnostic Medical — ZINNANTI SURGICAL DESIGN GROUP INC
- Diagnostic Medical — ZINNANTI SURGICAL DESIGN GROUP INC
- Zinnanti Surgical — ZINNANTI SURGICAL DESIGN GROUP INC
- Zinnanti Surgical — ZINNANTI SURGICAL DESIGN GROUP INC
- Zinnanti Surgical — ZINNANTI SURGICAL DESIGN GROUP INC
- Zinnanti Surgical — ZINNANTI SURGICAL DESIGN GROUP INC
- Zinnanti Surgical — ZINNANTI SURGICAL DESIGN GROUP INC
- Zinnanti Surgical — ZINNANTI SURGICAL DESIGN GROUP INC
- Zinnanti Surgical — ZINNANTI SURGICAL DESIGN GROUP INC
- Zinnanti Surgical — ZINNANTI SURGICAL DESIGN GROUP INC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zinnanti Surgical Design Group Inc
Sources (1)
- FDA UDI a22ed5b7-a75c-4e29-aa70-42835aecaf8f 34 fields · synced Jun 8, 2026