Identity
- Trade Name
- Cathay FDA UDI
- Generic Name
- Electrosurgical return electrode, single-use FDA UDI
- Device Name
- Pediatric use, monopolar, with cable; disposable neutral electrode FDA UDI
- Model / Reference
- GP202D-PCB FDA UDI
- Description
- Pediatric use, monopolar, with cable; disposable neutral electrode FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06959006300789 FDA UDI
- 510(k) Number
- K130027 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrosurgical return electrode, 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
No
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
MR Unsafe FDA UDI
Category: Electrosurgical return electrode, single-use
Cathay by Cathay Manufacturing Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K130027 also covers:
- ROSPITAL PRODUCTOS MEDICOS — ATLAS MEDICAL PRODUCTS LLC
- CATHAY — CATHAY MANUFACTURING CORP.
- CATHAY — CATHAY MANUFACTURING CORP.
- CATHAY — CATHAY MANUFACTURING CORP.
- Cathay — CATHAY MANUFACTURING CORP.
- Cathay — CATHAY MANUFACTURING CORP.
- Cathay — CATHAY MANUFACTURING CORP.
- Cathay — CATHAY MANUFACTURING CORP.
- Cathay — CATHAY MANUFACTURING CORP.
- Cathay — CATHAY MANUFACTURING CORP.
- Cathay — CATHAY MANUFACTURING CORP.
- Cathay — CATHAY MANUFACTURING CORP.
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
- Cathay Manufacturing Corp.
Sources (1)
- FDA UDI 30ee6128-b0e9-45d6-8761-2f49d7dbf9d0 34 fields · synced May 30, 2026