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Bioventus Clinician Kit

FDA UDI

Class II (US FDA UDI)

by Bioventus Llc

Identity

Trade Name
Bioventus Clinician Kit FDA UDI
Generic Name
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer FDA UDI
Model / Reference
PNS-1000 FDA UDI

Identifiers

Primary DI / UDI-DI
00816986020624 FDA UDI
FDA Product Code
GZF FDA UDI
GMDN Term
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer

Bioventus Clinician Kit by Bioventus Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bioventus Llc

Sources (1)

  • FDA UDI 8ce35305-497f-475b-8440-6d3d9a903fad 33 fields · synced May 29, 2026