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Insulating Waterproof ePTFE Pouch

FDA UDI

Class II (US FDA UDI)

by General Vibronics, Inc.

Identity

Trade Name
Insulating Waterproof ePTFE Pouch FDA UDI
Generic Name
Medium-wave diathermy treatment system generator FDA UDI
Model / Reference
GV-EPTFE-01 FDA UDI

Identifiers

Primary DI / UDI-DI
00860013508647 FDA UDI
510(k) Number
K242553 FDA UDI
FDA Product Code
PBX FDA UDI
GEI FDA UDI
GMDN Term
Medium-wave diathermy treatment system generator 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

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Medium-wave diathermy treatment system generator

Insulating Waterproof ePTFE Pouch by General Vibronics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medium-wave diathermy treatment system generator.

Cleared under the same submission

K242553 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
General Vibronics, Inc.

Sources (1)

  • FDA UDI 797683e1-ab31-43c5-a8c7-1181ef90c337 33 fields · synced May 31, 2026