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Spectrum, Inc. 982-03615-000

by Spectrum Co.

Spectrum, Inc. 982-03615-000 (721247) is a Class I device made by Spectrum Co., listed in FDA GUDID since 21 Jul 2017 (UDI-DI 00850301007761), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850301007761 UDI-DI Date21 Jul 2017ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Spectrum, Inc.
Generic name
Custom-made cushion
Model / Ref / Catalog
982-03615-000, 721247
Primary DI / UDI-DI
00850301007761
FDA product code
KIC
GMDN term
Custom-made cushion
Device class
Class I
Regulation number
890.3175
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Similar devices

Other devices filed under FDA product code KIC (CUSHION, FLOTATION).

Other devices from Spectrum Co.

See all devices from Spectrum Co. →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)