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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
Endoscopic electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
Device Name
Reusable Push Button Pencil With Stamping Blade ,3M Cable FDA UDI
Model / Reference
JAU-3092-R FDA UDI
Description
Reusable Push Button Pencil With Stamping Blade ,3M Cable FDA UDI

Identifiers

Primary DI / UDI-DI
B461JAU3092R0 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Endoscopic electrosurgical handpiece/electrode, monopolar, reusable 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

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 Endoscopic electrosurgical handpiece/electrode, monopolar, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Jac Cell Usa Inc

Sources (1)

  • FDA UDI e74d3755-ba16-4aab-a054-f3da9c6be034 33 fields · synced May 30, 2026