← Back to catalogue

Jac-cell USA Inc.

FDA UDI

Class II (US FDA UDI)

by Jac Cell Usa Inc

Identity

Trade Name
Jac-cell USA Inc. FDA UDI
Generic Name
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
Device Name
PENCIL, Push Button w/SS Blade&Holster Disposable FDA UDI
Model / Reference
JAU-1422 FDA UDI
Description
PENCIL, Push Button w/SS Blade&Holster Disposable FDA UDI

Identifiers

Primary DI / UDI-DI
B461JAU142213 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Open-surgery electrosurgical handpiece/electrode, monopolar, 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

Jac-cell USA Inc. by Jac Cell Usa Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Open-surgery electrosurgical handpiece/electrode, monopolar, single-use.

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
Jac Cell Usa Inc

Sources (1)

  • FDA UDI f4ca521b-d8eb-4097-985e-1940ecee4603 33 fields · synced Jun 6, 2026