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PlasmaJet Neutral Plasma Surgery System

FDA UDI

Class II (US FDA UDI)

by Plasma Surgical, Ltd.

Identity

Trade Name
PlasmaJet Neutral Plasma Surgery System FDA UDI
Generic Name
Plasma surgical system handpiece FDA UDI
Device Name
Single-Use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System FDA UDI
Model / Reference
OS-CG 05-12H FDA UDI
Description
Single-Use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System FDA UDI

Identifiers

Catalog Number
OS-CG 05-12H FDA UDI
Primary DI / UDI-DI
M397OSCG0512H0 FDA UDI
510(k) Number
K121977 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Plasma surgical system handpiece 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

Dimensions & Sizes

Size
Length — 12 Centimeter FDA UDI

Category: Plasma surgical system handpiece

PlasmaJet Neutral Plasma Surgery System by Plasma Surgical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Plasma surgical system handpiece.

Cleared under the same submission

K121977 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Plasma Surgical, Ltd.

Sources (1)

  • FDA UDI 70e1ba96-fbff-4b8f-8c78-f3396bdc2618 37 fields · synced May 29, 2026