Transcend PRP TP0100

by Aeon Biotherapeutics Corp.

Transcend PRP TP0100 is a Class II device made by Aeon Biotherapeutics Corp., listed in FDA GUDID since 7 Aug 2025 (UDI-DI 04719875912245), 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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04719875912245 UDI-DI	Date7 Aug 2025Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 04719875912245

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Transcend PRP
Generic name: Haematological concentrate system preparation kit, platelet concentration
Model / reference: TP0100

Primary DI / UDI-DI: 04719875912245
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 in this category

Other devices filed under Haematological concentrate system preparation kit, platelet concentration.

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)