Monoject SC4508

by Cardinalhealth

Monoject SC4508 is a Class I device made by Cardinalhealth, listed in FDA GUDID since 27 Jun 2018 (UDI-DI 10884521020436), 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	Number10884521020436 UDI-DI	Date27 Jun 2018Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 10884521020436

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Monoject
Generic name: Bone marrow biopsy procedure kit
Model / Ref / Catalog: SC4508

Primary DI / UDI-DI: 10884521020436
FDA product code: GAA
GMDN term: Bone marrow biopsy procedure kit

Device class: Class I
Regulation number: 878.4800
GUDID distribution status: In Commercial Distribution

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Properties

Supplied sterile
Single use
Prescription use
Premarket exempt
Lot / batch number
Expiration date

Other properties (9, all answered No)