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Pixa 85-10-4000

by Santa Barbara Imaging Systems, Inc.

Pixa 85-10-4000 is a Class II device made by Santa Barbara Imaging Systems, Inc., listed in FDA GUDID since 22 Aug 2018 (UDI-DI 00853460007283), 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 Number00853460007283 UDI-DI Date22 Aug 2018ListedStatusListed 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  • Withdrawn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
Pixa
Generic name
Endoscopic video image processing unit
Model / Ref / Catalog
85-10-4000
Primary DI / UDI-DI
00853460007283
FDA product code
GCJ
GMDN term
Endoscopic video image processing unit
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)