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Freedom System Accessories

FDA UDI

Class II (US FDA UDI)

by Curonix

Identity

Trade Name
Freedom System Accessories FDA UDI
Generic Name
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable FDA UDI
Device Name
28" Antenna w/Velcro - Large FDA UDI
Model / Reference
00-89128 FDA UDI
Description
28" Antenna w/Velcro - Large FDA UDI

Identifiers

Primary DI / UDI-DI
00850051034710 FDA UDI
FDA Product Code
GZB FDA UDI
GZF FDA UDI
GMDN Term
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5880 FDA UDI
882.5870 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable

Freedom System Accessories by Curonix — 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 pulse generator, implantable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Curonix

Sources (1)

  • FDA UDI 806367ac-14ee-49dd-9807-8b515236142c 33 fields · synced May 30, 2026