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Triworks Group srl

FDA UDI

Class II (US FDA UDI)

by Triworks Group Srl

Identity

Trade Name
Triworks Group srl FDA UDI
Generic Name
Nitrogen plasma skin surface treatment system FDA UDI
Device Name
Plasma device FDA UDI
Model / Reference
AgeJet FDA UDI
Description
Plasma device FDA UDI

Identifiers

Primary DI / UDI-DI
08057168020007 FDA UDI
510(k) Number
K212472 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Nitrogen plasma skin surface treatment system 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

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Nitrogen plasma skin surface treatment system

Triworks Group srl by Triworks Group Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nitrogen plasma skin surface treatment system.

Cleared under the same submission

K212472 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Triworks Group Srl

Sources (1)

  • FDA UDI 18e1b25b-2558-428e-b52d-9123fe5d979a 34 fields · synced Jun 6, 2026