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Virtue ACKit ACK-D15P

by Aeon Biotherapeutics Corp.

Virtue ACKit ACK-D15P is a Class II device made by Aeon Biotherapeutics Corp., listed in FDA GUDID since 24 Sep 2026 (UDI-DI 04719875912290), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04719875912290 UDI-DI Date24 Sep 2026ListedStatusListed 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  • Withdrawn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
Virtue ACKit
Generic name
Haematological concentrate system preparation kit, platelet concentration
Model / reference
ACK-D15P
Primary DI / UDI-DI
04719875912290
FDA product code
ORG
GMDN term
Haematological concentrate system preparation kit, platelet concentration
Device class
Class II
Regulation number
864.9245
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code ORG (Platelet And Plasma Separator For Bone Graft Handling).

Other devices from Aeon Biotherapeutics Corp.

See all devices from Aeon Biotherapeutics Corp. →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)