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ACELL, INC.

Last updated September 17, 2026

Information

Country: US
Address: 6640 Eli Whitney Dr Ste 200, Columbia, MD, 21046
Website: acell.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)826-2926
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3005920706
DUNS Number: 137258252

Catalogue (222)

Page 3 of 5

Device	Model / Reference	Registries	Class	Status
Cytal®	WSR0505	FDA UDI	U	Unknown
MicroMatrix®	MM0100F	FDA UDI	U	Active
MatriStem	SMRS0710	FDA UDI	Class II	Unknown
MatriStem	PSM1015	FDA UDI	Class II	Unknown
Gentrix®	PSM0505	FDA UDI	Class II	Active
MatriStem	PSMT2025	FDA UDI	Class II	Unknown
MediHoney®	31644	FDA UDI	U	Active
Tcc-Ez®	TCC24024	FDA UDI	Class I	Unknown
Tcc-Ez®	TCC21126	FDA UDI	Class I	Active
Gentrix®	PSMT3030	FDA UDI	Class II	Active
Tcc-Ez®	TCC23002	FDA UDI	Class I	Active
Gentrix®	PSM1015	FDA UDI	Class II	Active
MatriStem	PSMT2035	FDA UDI	Class II	Unknown
MicroMatrix®	MM0200	FDA UDI	U	Active
MedE-Kast®	TCC2FCT03	FDA UDI	Class I	Active
Gentrix®	PSMX1015	FDA UDI	Class II	Active
Gentrix®	PSMT1630	FDA UDI	Class II	Unknown
Gentrix®	MSPL0710	FDA UDI	Class II	Active
MatriStem	WS0307	FDA UDI	U	Unknown
Gentrix®	HIAT0706	FDA UDI	Class II	Active
Cytal®	WSR0505	FDA UDI	U	Active
Cardion™	PP1015	FDA UDI	Class II	Active
MatriStem	PSMX0710	FDA UDI	Class II	Unknown
MatriStem	PSMX0615	FDA UDI	Class II	Unknown
Cytal®	WS1015	FDA UDI	U	Unknown
Gentrix®	PSMT1020B	FDA UDI	Class II	Active
MediHoney®	31844	FDA UDI	U	Active
Cytal®	WSX0505	FDA UDI	U	Active
MedE-Kast®	TCC2GSII	FDA UDI	Class I	Active
Cytal®	WS1015	FDA UDI	U	Active
Gentrix®	PSM0710	FDA UDI	Class II	Active
MicroMatrix®	MM0020	FDA UDI	U	Active
MatriStem	PFM0505	FDA UDI	Class II	Unknown
Gentrix®	PSM0710	FDA UDI	Class II	Active
MatriStem	PSMX0505	FDA UDI	Class II	Unknown
Gentrix®	LRM0406	FDA UDI	Class II	Unknown
MatriStem	PFM0912	FDA UDI	Class II	Unknown
Gentrix®	PSM0412	FDA UDI	Class II	Active
Cytal®	BMM1015	FDA UDI	U	Unknown
Gentrix®	PSMT2025	FDA UDI	Class II	Active
MatriStem	PSMT3040	FDA UDI	Class II	Unknown
MatriStem	MM0060	FDA UDI	U	Unknown
MatriStem	BMM0505	FDA UDI	U	Unknown
Gentrix®	MSPL0507	FDA UDI	Class II	Active
MEDIHONEY® Hydrogel	31740	FDA UDI	U	Active
Cytal®	WS0303	FDA UDI	U	Active
ACell®	PFM0710	FDA UDI	Class II	Unknown
Cytal®	WSR0710	FDA UDI	U	Unknown
MatriStem	PSMX0816	FDA UDI	Class II	Unknown
Gentrix®	PSM0615	FDA UDI	Class II	Active

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Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Feb 14, 2019	Z-1033-2019	—	terminated	The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.
Feb 14, 2019	Z-1032-2019	—	terminated	The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.
Jul 7, 2011	Z-2855-2011	—	terminated	Surgical mesh for implantation may have elevated endotoxin levels.