← Back to catalogue

TalisMann Implant Kit

FDA UDI

Class II (US FDA UDI)

by Bioventus Llc

Identity

Trade Name
TalisMann Implant Kit FDA UDI
Generic Name
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wireless connection FDA UDI
Model / Reference
TM-1000 FDA UDI

Identifiers

Primary DI / UDI-DI
00816986020549 FDA UDI
FDA Product Code
GZF FDA UDI
GMDN Term
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wireless connection 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

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wireless connection

TalisMann Implant 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 lead, wireless connection.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Bioventus Llc

Sources (1)

  • FDA UDI 13af7784-c8ef-4698-a920-c1d170346e3f 34 fields · synced Jun 1, 2026