Avivatens Pain Management

FDA UDI

Class II (US FDA UDI)

by Bio-Medical Research, Ltd.

Identity

Trade Name: Avivatens Pain Management FDA UDI
Generic Name: Transcutaneous electrical stimulation lead FDA UDI
Model / Reference: 439, 438, 413 FDA UDI

Identifiers

Catalog Number: 0439-5006 FDA UDI
Primary DI / UDI-DI: 15099058439001 FDA UDI
FDA Product Code: NYN FDA UDI
GZJ FDA UDI
IPF FDA UDI
GMDN Term: Transcutaneous electrical stimulation lead FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5890 FDA UDI
890.5850 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Transcutaneous electrical stimulation electrode, single-use Physical therapy transcutaneous neuromuscular electrical stimulation system Transcutaneous electrical stimulation lead

Avivatens Pain Management by Bio-Medical Research, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Bio-Medical Research, Ltd.

Sources (1)

FDA UDI 72bc05b3-a655-4195-a6a2-91ddbdb7bd7a 33 fields · synced May 30, 2026