Bio Protech

FDA UDI

Class II (US FDA UDI)

by Bio Protech Usa, Inc.

Identity

Trade Name: Bio Protech FDA UDI
Generic Name: Electromyographic needle electrode, single-use FDA UDI
Device Name: BCS-15 (Lifelines) - Lifelines OEM, Corkscrew needle, 150cm wire length, 1.5mm female TP connector FDA UDI
Model / Reference: BCS-15 (Lifelines) FDA UDI
Description: BCS-15 (Lifelines) - Lifelines OEM, Corkscrew needle, 150cm wire length, 1.5mm female TP connector FDA UDI

Identifiers

Primary DI / UDI-DI: 00817120021347 FDA UDI
FDA Product Code: GXZ FDA UDI
IKT FDA UDI
GMDN Term: Electromyographic needle electrode, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1350 FDA UDI
890.1385 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electromyographic needle electrode, single-use

Bio Protech by Bio Protech Usa, Inc. — 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 Protech Usa, Inc.

Sources (1)

FDA UDI fb84e4db-007c-4727-815e-3b916b62422d 34 fields · synced Jun 1, 2026