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StimRouter Implantable Kit

FDA UDI

Class II (US FDA UDI)

by Bioness Inc.

Identity

Trade Name
StimRouter Implantable Kit FDA UDI
Generic Name
Analgesic PENS system probe, single-use FDA UDI
Device Name
StimRouter Implantable Lead FDA UDI
Model / Reference
ST2-1000 FDA UDI
Description
StimRouter Implantable Lead FDA UDI

Identifiers

Primary DI / UDI-DI
00815962020016 FDA UDI
FDA Product Code
GZF FDA UDI
GMDN Term
Analgesic PENS system probe, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5870 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Length — 15 Centimeter FDA UDI

Category: Analgesic PENS system probe, single-use

StimRouter Implantable Kit by Bioness Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Analgesic PENS system probe, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bioness Inc.

Sources (1)

  • FDA UDI 17f6e99a-4a74-49d5-a8f9-268bd1a42f1c 36 fields · synced May 30, 2026