Identity
- Trade Name
- WALLACH FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- Integration Unit (120 VAC) FDA UDI
- Model / Reference
- 909080 FDA UDI
- Description
- Integration Unit (120 VAC) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937014006 FDA UDI
- 510(k) Number
- K963348 FDA UDI
- FDA Product Code
- HGI FDA UDI
- GMDN Term
- Electrosurgical system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4120 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrosurgical system
Wallach by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K963348 also covers:
- Dual Dispersive Electrodes with Connector — CooperSurgical, Inc.
- Dual Dispersive Electrodes without Connector — CooperSurgical, Inc.
- Foot Pedal-Operated Cautery Pencil — CooperSurgical, Inc.
- Hand Switch-Operated Cautery Pencil — CooperSurgical, Inc.
- LEEP PRECISION™ Integrated System — CooperSurgical, Inc.
- LEEP PRECISION™ Integrated System — CooperSurgical, 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
- CooperSurgical, Inc.
Sources (1)
- FDA UDI acd6697d-0a29-4be7-8820-4f6edfa391bd 34 fields · synced Jun 9, 2026