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Spetzler Neuro Patties K Series

by Omt, LLC 35 variants

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 NumberM731K90099 UDI-DI Date31 Dec 2025ListedStatusListed 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  • Withdrawn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
Spetzler Neuro Patties
Generic Name
Cottonoid pad
Model / Ref / Catalog
K Series, K-9009
Primary DI / UDI-DI
M731K90099
510(k) Number
FDA Product Code
HBA
GMDN Term
Cottonoid pad
Device Class
Class II
Regulation Number
882.4700
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K020736)

Show all (12)

Other devices from Omt, LLC

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Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No