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Tea Snm-FDC01

by Transtimulation Research Inc

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00196852517596 UDI-DI Date18 Jun 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Tea
Generic Name
Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
Model / Reference
SNM-FDC01
Primary DI / UDI-DI
00196852517596
510(k) Number
FDA Product Code
QHH
GMDN Term
Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
Device Class
Class II
Regulation Number
876.5340
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Other devices from Transtimulation Research Inc

Properties

  • Prescription Use

Other properties (13)

  • 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No