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Strap, Head Positioning 81-05336-000

by Neuronetics Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 2 Nov 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10850005944970 UDI-DI Date21 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 2 Nov 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Strap, Head Positioning
Generic Name
Magnetic neural stimulation system
Model / Reference
81-05336-000
Primary DI / UDI-DI
10850005944970
510(k) Number
FDA Product Code
OBP, QCI
GMDN Term
Magnetic neural stimulation system
Device Class
Class II
Regulation Number
882.5805, 882.5802
GUDID distribution status
In Commercial Distribution

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Other devices from Neuronetics Inc.

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Properties

  • Single Use
  • Prescription Use
  • Manufacturing Date

Other properties (11)

  • Sterile: 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