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K-Ball 01BK0001

by S.M.A.I.O

K-Ball 01BK0001 is a Class I device made by S.M.A.I.O, listed in FDA GUDID since 22 Dec 2023 (UDI-DI 03701313007942), 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 Number03701313007942 UDI-DI Date22 Dec 2023ListedStatusListed 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  • Withdrawn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
K-Ball
Generic name
CT phantom, test object
Model / Ref / Catalog
01BK0001
Primary DI / UDI-DI
03701313007942
FDA product code
JAC
GMDN term
CT phantom, test object
Device class
Class I
Regulation number
892.1640
GUDID distribution status
In Commercial Distribution

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Category: CT phantom, test object

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Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (10, all answered No)