ACELL, INC.

Matched from indexed company URL: ACell, Inc.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3005920706	3005920706	ACELL, INC.	1	N	2026-01-01	6640 Eli Whitney Dr Ste 200 Columbia MD US 21046
3004555298	3004555298	ACell, Inc.	1	N	2020-04-25	3589 Sagamore Parkway North, Suite 220 Lafayette IN US 47904
3005920706	3005920706	ACELL, INC.	1	Y	2020-04-25	6640 Eli Whitney Dr Ste 200 Columbia MD US 21046

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00386190001820	Cytal® - Cytal® Wound Matrix 3-Layer, 16cm x 25cm	+1(800)826-2926	customerservice@acell.com

acell.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
289036	1689470698	K241724	Cytal® Wound Matrix; Cytal® Burn Matrix	KGN	2024-07-11
289036	1342728165	K241706	MicroMatrix® UBM Particulate	KGN	2024-07-11
289036	1146857950	K230980	MicroMatrix® Flex	KGN	2023-09-22
104980	1130982375	K192725	Cytal Wound Matrix 3-Layer	KGN	2019-10-25
289036	1467881936	K192725	Cytal Wound Matrix 3-Layer	KGN	2019-10-25
289036	1249324040	K191734	MatriStem UBM Pericardial Patch	PSQ	2019-11-22
104980	2047586850	K191734	MatriStem UBM Pericardial Patch	PSQ	2019-11-22
289036	1027869255	K182259	Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal	FTM	2019-02-07
91034	1863832736	K182259	Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal	FTM	2019-02-07
104980	1863832736	K182259	Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal	FTM	2019-02-07
289036	1446841775	K172399	MicroMatrix	KGN	2017-10-06
104980	1776880268	K172399	MicroMatrix	KGN	2017-10-06
91034	1776880268	K172399	MicroMatrix	KGN	2017-10-06
91034	1871682762	K170763	Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend	FTM	2017-06-08
104980	1871682762	K170763	Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend	FTM	2017-06-08
289036	1938214924	K170763	Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend	FTM	2017-06-08
104980	1171975287	K162554	Gentrix Surgical Matrix	FTM	2016-10-21
91034	1171975287	K162554	Gentrix Surgical Matrix	FTM	2016-10-21
91034	1459315567	K153754	MicroMatrix	KGN	2016-03-14
104980	1459315567	K153754	MicroMatrix	KGN	2016-03-14
104980	1494906811	K152721	Cytal Wound Matrix	KGN	2015-12-08
91034	1494906811	K152721	Cytal Wound Matrix	KGN	2015-12-08
289036	2011716896	K152721	Cytal Wound Matrix	KGN	2015-12-08
289036	1447220566	K150985	Medihoney Wound Gel	FRO	2015-11-19
289036	1324713683	K110546	MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY	FRO	2011-07-27
289036	1259386103	K101793	MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY	FRO	2011-02-22
289036	1355020156	K080315	DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY	FRO	2008-04-23
289036	1775000217	K072956	MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY	FRO	2007-11-07
289036	1112830902	K053095	HONEY ALGINATE DRESSING	FRO	2007-07-12
104980	1199573196	K040621	ACELL UBM SURGICAL MESH	FTM	2004-04-14
104980	1172209451
104980	1183133095
104980	1230761454
104980	1496196071
104980	1607608323
104980	1890179788
104980	1999139331
289036	1886910461

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
KGN	13	2024-07-11
FTM	9	2019-02-07
FRO	6	2015-11-19
PSQ	2	2019-11-22

PMN#

Cytal® Wound Matrix; Cytal® Burn Matrix
2024-07-11
Acell, Inc.
MicroMatrix® UBM Particulate
2024-07-11
Acell, Inc.
MicroMatrix® Flex
2023-09-22
Acell, Inc.
MatriStem UBM Pericardial Patch
2019-11-22
Acell, Inc.
Cytal Wound Matrix 3-Layer
2019-10-25
ACell, Inc.
Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal
2019-02-07
ACell, Inc.
Cytal Wound Particulate
2018-05-11
ACell, Inc.
MicroMatrix
2017-10-06
ACell, Inc.
Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend
2017-06-08
ACell, Inc.
Gentrix Surgical Matrix
2016-10-21
Acell, Inc.

GUDID#

MEDIHONEY® - MEDIHONEY® Gel Dressing with Active Leptospermum Honey
ACELL, INC.
2019-03-07
MediHoney® - MEDIHONEY® Dressing with Active Leptospermum Honey Wound and Burn Dressing
ACELL, INC.
2018-08-30
MediHoney® - MEDIHONEY® Dressing with Active Leptospermum Honey Wound and Burn Dressing
ACELL, INC.
2018-08-28
MediHoney® - MEDIHONEY® Gel Dressing with Active Leptospermum Honey Wound & Burn Dressing
ACELL, INC.
2018-08-30
MediHoney® - MEDIHONEY® Dressing with Active Leptospermum Honey Wound and Burn Dressing
ACELL, INC.
2019-03-06
MediHoney® - MEDIHONEY® Gel Dressing with Active Leptospermum Honey Wound and Burn Dressing
ACELL, INC.
2018-09-14
MicroMatrix® - MicroMatrix® Flex 5cc
ACELL, INC.
2023-10-02
Cytal® - Cytal® Wound Matrix 3-Layer, 16cm x 25cm
ACELL, INC.
2019-12-16
Cytal® - Cytal® Wound Matrix 3-Layer, 16cm x 35cm
ACELL, INC.
2019-12-16
MatriStem - MicroMatrix, 20 mg
ACELL, INC.
2017-01-10
MatriStem - MicroMatrix, 30 mg
ACELL, INC.
2017-01-10
MatriStem - MatriStem Wound Sheet, 3 X 3.5 cm
ACELL, INC.
2017-01-10
MatriStem - MatriStem Wound Sheet, 3 X 7 cm
ACELL, INC.
2017-01-10
MatriStem - MatriStem Wound Sheet, 7 X 10 cm
ACELL, INC.
2017-01-10
MatriStem - MatriStem Wound Sheet, 10 X 15 cm
ACELL, INC.
2017-01-10
MatriStem - MicroMatrix, 60 mg
ACELL, INC.
2017-01-10
MatriStem - MicroMatrix, 100 mg
ACELL, INC.
2017-01-10
MatriStem - MicroMatrix, 100 mg Fine Particulate
ACELL, INC.
2017-01-10
MicroMatrix® - Gentrix® Standard Particulate 200 mg
ACELL, INC.
2017-01-10
MatriStem - MicroMatrix, 200 mg Fine Particulate
ACELL, INC.
2017-01-10
MatriStem - MicroMatrix, 500 mg
ACELL, INC.
2017-01-10
MatriStem - MicroMatrix, 1000 mg
ACELL, INC.
2017-01-10
MatriStem - Burn Matrix Meshed 5X5cm
ACELL, INC.
2017-01-10
MatriStem - Burn Matrix Meshed 7X10cm
ACELL, INC.
2017-01-10
MatriStem - Burn Matrix Meshed 10X15cm
ACELL, INC.
2017-01-10
MatriStem - Multilayer Wound Matrix 5 X 5 cm
ACELL, INC.
2017-01-10
MatriStem - Multilayer Wound Matrix 7 X 10 cm
ACELL, INC.
2017-01-10
MatriStem - Multilayer Wound Matrix 10 X 15 cm
ACELL, INC.
2017-01-10
Cytal® - Cytal® Wound Matrix 3-Layer 5 X 5 cm
ACELL, INC.
2017-01-10
Cytal® - Cytal® Wound Matrix 3-Layer 7 X 10 cm
ACELL, INC.
2017-01-10
Cytal® - Cytal® Wound Matrix 3-Layer 10 X 15 cm
ACELL, INC.
2017-01-10
Cytal® - Cytal® Wound Matrix 6-Layer 5 X 5 cm
ACELL, INC.
2017-01-10
Cytal® - Cytal® Wound Matrix 6-Layer 7 X 10 cm
ACELL, INC.
2017-01-10
Cytal® - Cytal® Wound Matrix 6-Layer 10 X 15 cm
ACELL, INC.
2017-01-10
Cytal® - Burn Matrix 10 X 15 cm
ACELL, INC.
2017-01-10
Cytal® - Burn Matrix 7 X 10 cm
ACELL, INC.
2017-01-10
Cytal® - Burn Matrix 5 X 5 cm
ACELL, INC.
2017-01-10
Cytal® - Cytal® Wound Matrix 2-Layer 5 X 5 cm
ACELL, INC.
2017-01-10
Cytal® - Cytal® Wound Matrix 2-Layer 7 X 10 cm
ACELL, INC.
2017-01-10
Cytal® - Cytal® Wound Matrix 2-Layer 10 X 15 cm
ACELL, INC.
2017-01-10

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