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Pro-Tec

FDA UDI

Class I (US FDA UDI)

by Dectro International

Identity

Trade Name
Pro-Tec FDA UDI
Generic Name
Hair-removal electrolysis system needle electrode, single-use FDA UDI
Device Name
Hair-removal electrolysis probe, single-use FDA UDI
Model / Reference
IsoGard F5 FDA UDI
Description
Hair-removal electrolysis probe, single-use FDA UDI

Identifiers

Catalog Number
05-0205 FDA UDI
Primary DI / UDI-DI
00686209052059 FDA UDI
FDA Product Code
KCW FDA UDI
GMDN Term
Hair-removal electrolysis system needle electrode, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.5350 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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Hair-removal electrolysis system needle electrode, single-use

Pro-Tec by Dectro International — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hair-removal electrolysis system needle electrode, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dectro International

Sources (1)

  • FDA UDI 8a9f7599-52d1-4140-a5bb-542e15da081e 34 fields · synced Jun 8, 2026