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PlasmaJet Neutral Plasma Surgery System OS-CG-05-12

by Plasma Surgical, Ltd.

Ref OS-CG-05-12

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-++M397OSCG05120DY Basic UDI-DI ++M397OSCG05120DYUDI-DIDate12 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number++M397OSCG05120DY UDI-DI Date1 Oct 2018ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
PlasmaJet Neutral Plasma Surgery System
Generic Name
Plasma surgical system handpiece
Device Name
PlasmaJet Neutral Plasma Handpiece
Model / Ref / Catalog
OS-CG-05-12
Primary DI / UDI-DI
++M397OSCG05120DY EUDAMED
M397OSCG05120 GUDID
Basic UDI-DI
B-++M397OSCG05120DY
510(k) Number
FDA Product Code
GEI
EMDN Code
K020480 Devices for surgery with argon gas generator, single-use- accessories
GMDN Term
Plasma surgical system handpiece
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4400
Market of Registration
France
GUDID distribution status
In Commercial Distribution
Size
Length — 12 Centimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
++M397OSCG05120DY
GUDID
M397OSCG05120
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K121977)

Show all (12)

Other devices from Plasma Surgical, Ltd.

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No