Identity
- Trade Name
- Arms Medical FDA UDI
- Generic Name
- Electrosurgical handpiece, single-use FDA UDI
- Device Name
- Smoke-Evacuation Electrosurgical Pencil FDA UDI
- Model / Reference
- SEP2A FDA UDI
- Description
- Smoke-Evacuation Electrosurgical Pencil FDA UDI
Identifiers
- Catalog Number
- SEP2A FDA UDI
- Primary DI / UDI-DI
- G373SEP2A0 FDA UDI
- 510(k) Number
- K092634 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrosurgical handpiece, 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: Electrosurgical handpiece, single-use
Arms Medical by Zinnanti Surgical Design Group Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K092634 also covers:
- 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
- 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 |
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Manufacturer
- Manufacturer
- Zinnanti Surgical Design Group Inc
Sources (1)
- FDA UDI 1638a596-8ade-42fe-b024-74193aef358c 35 fields · synced Jun 1, 2026