← Back to catalogue

US Medical Innovations

FDA UDI

Class II (US FDA UDI)

by Us Medical Innovations, Llc

Identity

Trade Name
US Medical Innovations FDA UDI
Generic Name
Inert gas-enhanced electrosurgical system generator FDA UDI
Device Name
Canady Plasma SMART Electrosurgical Generator FDA UDI
Model / Reference
XL-1000 FDA UDI
Description
Canady Plasma SMART Electrosurgical Generator FDA UDI

Identifiers

Catalog Number
XL1000 FDA UDI
Primary DI / UDI-DI
B413XL10000 FDA UDI
510(k) Number
K192124 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Inert gas-enhanced electrosurgical system generator 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

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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: Inert gas-enhanced electrosurgical system generator

US Medical Innovations by Us Medical Innovations, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Inert gas-enhanced electrosurgical system generator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Us Medical Innovations, Llc

Sources (1)

  • FDA UDI 0c9eda08-d8b3-491f-9a1a-fcf1b5978573 35 fields · synced May 30, 2026