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Therapy Disc 34001-001

by Nalu Medical 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00812537030234 UDI-DI Date19 Jan 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Therapy Disc
Generic Name
Implantable spinal cord electrical stimulation system programmer
Model / Ref / Catalog
34001-001
Primary DI / UDI-DI
00812537030234
FDA Product Code
GZF, GZB
GMDN Term
Implantable spinal cord electrical stimulation system programmer
Device Class
Class II
Regulation Number
882.5870, 882.5880
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Other devices from Nalu Medical

See all devices from Nalu Medical →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No