Pretika

FDA UDI

Class II (US FDA UDI)

by Pretika Corporation

Identity

Trade Name: Pretika FDA UDI
Generic Name: Transcutaneous electrical stimulation lead FDA UDI
Device Name: SonicLift 2.0 FDA UDI
Model / Reference: ST288 FDA UDI
Description: SonicLift 2.0 FDA UDI

Identifiers

Catalog Number: ST288 FDA UDI
Primary DI / UDI-DI: 00813859002886 FDA UDI
FDA Product Code: NFO FDA UDI
IRO FDA UDI
GET FDA UDI
GMDN Term: Transcutaneous electrical stimulation lead FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5890 FDA UDI
890.5975 FDA UDI
878.4820 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

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Transcutaneous electrical stimulation lead

Pretika by Pretika Corporation — 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: Pretika Corporation

Sources (1)

FDA UDI a023ac56-cf89-4268-adaa-2b9f43ad3bab 35 fields · synced May 30, 2026