Identity
- Trade Name
- ArC SMART FDA UDI
- Generic Name
- Electrosurgical return electrode, single-use FDA UDI
- Device Name
- The ArC SMART Argon Probe 3.2/220 is for exclusive use with the gi4000 Electrosurgical Unit. FDA UDI
- Model / Reference
- ArC SMART Probe FDA UDI
- Description
- The ArC SMART Argon Probe 3.2/220 is for exclusive use with the gi4000 Electrosurgical Unit. FDA UDI
Identifiers
- Catalog Number
- G1140003 FDA UDI
- Primary DI / UDI-DI
- 00724995209100 FDA UDI
- 510(k) Number
- K130983 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
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
No
FDA UDI
Category: Electrosurgical return electrode, single-use
ArC SMART by US Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K130983 also covers:
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
- US Endoscopy
Sources (1)
- FDA UDI 54df171c-01f0-4214-97ac-e1d5b2b48b86 37 fields · synced Jun 1, 2026