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
00386190001509	Cytal® - Cytal® Wound Matrix 6-Layer, 7cm x 10cm	+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
104980	1871682762	K170763	Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend	FTM	2017-06-08
91034	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
91034	1171975287	K162554	Gentrix Surgical Matrix	FTM	2016-10-21
104980	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
91034	1494906811	K152721	Cytal Wound Matrix	KGN	2015-12-08
104980	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

NDC#

SODIUM SULFACETAMIDE and SULFUR
Acella Pharmaceuticals, LLC
SODIUM SULFACETAMIDE and SULFUR
SODIUM SULFACETAMIDE - SULFUR WASH
ACELLA PHARMACEUTICALS
SODIUM SULFACETAMIDE, SULFUR
SODIUM SULFACETAMIDE
Acella Pharmaceuticals, LLC
SODIUM SULFACETAMIDE
Sodium Sulfacetamide and Sulfur
Acella Pharmaceuticals, LLC
Sodium Sulfacetamide and Sulfur
Salicylic Acid
Acella Pharmaceuticals, LLC
SALICYLIC ACID
SALICYLIC ACID
Acella Pharmaceuticals, LLC
SALICYLIC ACID
Sodium Sulfacetamide 10 Sulfur 5 Cleanser
Acella Pharmaceuticals, LLC
Sulfacetamide Sodium and Sulfur
SODIUM SULFACETAMIDE, SULFUR
Acella Pharmaceuticals, LLC
Sodium Sulfacetamide and Sulfur
Sodium Sulfacetamide 9 Sulfur 4.5 Wash
Acella Pharmaceuticals, LLC
Sulfacetamide Sodium and Sulfur
Sodium Sulfacetamide 10 Sulfur 2 Cleanser
Acella Pharmaceuticals, LLC
Sulfacetamide Sodium and Sulfur
SODIUM SULFACETAMIDE, SULFUR
Acella Pharmaceuticals, LLC
Sodium Sulfacetamide and Sulfur
Sodium Sulfacetamide 10 Sulfur 2 cream
Acella Pharmaceuticals, LLC
Sulfacetamide Sodium and Sulfur
HYDROQUINONE 4%
Acella Pharmaceuticals, LLC
Hydroquinone
Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser
Acella Pharmaceuticals, LLC
SULFACETAMIDE SODIUM, SULFUR
BP Vit 3
Acella Pharmaceuticals, LLC
folic acid, pyridoxine hydrochloride, cyanocobalamin, omega-3 fatty acids, doconexent, icosapent and .beta.-sitosterol
PNV-Select
Acella Pharmaceuticals, LLC
VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, DL, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS FUMARATE, POTASSIU...
PNV-DHA
Acella Pharmaceuticals, LLC
ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine, folic acid, cyanocobalamin, calcium, ferrous fumarate, magnesium, doconexent
PNV-DHA
Acella Pharmaceuticals, LLC
ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine, folic acid, calcium, ferrous fumarate, doconexent
NP Thyroid 15
Acella Pharmaceuticals, LLC
LEVOTHYROXINE, LIOTHYRONINE
NP Thyroid 120
Acella Pharmaceuticals, LLC
LEVOTHYROXINE, LIOTHYRONINE
NP Thyroid 30
Acella Pharmaceuticals, LLC
LEVOTHYROXINE, LIOTHYRONINE
NP Thyroid 60
Acella Pharmaceuticals, LLC
LEVOTHYROXINE, LIOTHYRONINE
NP Thyroid 90
Acella Pharmaceuticals, LLC
LEVOTHYROXINE, LIOTHYRONINE
PNV-Omega
Acella Pharmaceuticals, LLC
ascorbic acid, cholecalciferol, .alpha.-tocopherol, pyridoxine, folic acid, cyanocobalamin, calcium corbonate, ferrous fumarate, potassium iodide, magnesium, doconexent, icosapent
Hyoscyamine Sulfate ODT
Acella Pharmaceuticals, LLC
hyoscyamine sulfate
Hyoscyamine Sulfate SL
Acella Pharmaceuticals, LLC
hyoscyamine sulfate
Hyoscyamine Sulfate TAB
Acella Pharmaceuticals, LLC
hyoscyamine sulfate
Nicotinamide
Acella Pharmaceuticals, LLC
Nicotinamide
Doxycycline
Acella Pharmaceuticals, LLC
Doxycycline hyclate
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide
Acella Pharmaceuticals, LLC
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
Gabapentin
Acella Pharmaceuticals, LLC
gabapentin
PHENYTOIN SODIUM
Acella Pharmaceuticals, LLC
PHENYTOIN SODIUM
Naproxen
Acella Pharmaceuticals, LLC
Naproxen
levonorgestrel and ethinyl estradiol
Acella Pharmaceuticals
levonorgestrel and ethinyl estradiol
Pyridostigmine Bromide
Acella Pharmaceuticals, LLC
pyridostigmine bromide
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide
Acella Pharmaceuticals, LLC
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
Ciclopirox
Acella Pharmaceuticals, LLC
Ciclopirox
Ciclopirox
Acella Pharmaceuticals, LLC
Ciclopirox

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.
MicroMatrix
2016-03-14
ACELL, INC
Cytal Wound Matrix
2015-12-08
ACELL, INC
Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix
2015-06-17
ACELL, INC
LOUTREX TOPICAL CREAM
2012-09-06
ACELLA PHARMACEUTICALS, LLC
MATRISTEM WOUND MATRIX
2011-08-29
ACELL, INC
ACELL MATRISTEM WOUND SHEET
2009-10-28
ACELL, INC
ACELL POWDER WOUND DRESSING
2006-06-23
ACELL, INC
ACELL UBM SURGICAL MESH ML AND MLPLUS
2004-07-07
ACELL, INC
ACELL UBM SURGICAL MESH
2004-04-14
ACELL, INC
ACELL UBM HYDRATED WOUND DRESSING
2002-12-30
ACELL, INC
ACELL UBM LYOPHILIZED WOUND DRESSING
2002-12-19
ACELL, INC

Applications#

218464
ACELLA
206891
ACELLA
203375
ACELLA
078172
ACELLA
076403
ACELLA PHARMS LLC
040573
ACELLA

GUDID#

MEDIHONEY® - MEDIHONEY® Gel Dressing with Active Leptospermum Honey
ACELL, INC.
2019-03-07
MediHoney® - MEDIHONEY® Gel Dressing with Active Leptospermum Honey Wound and Burn Dressing
ACELL, INC.
2018-09-14
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 & 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® Dressing with Active Leptospermum Honey Wound and Burn Dressing
ACELL, INC.
2018-08-30
Cytal® - Cytal® Wound Matrix 6-Layer, 10cm x 15cm
ACELL, INC.
2017-01-20
Cytal® - Cytal® Wound Matrix 6-Layer, 7cm x 10cm
ACELL, INC.
2017-01-20
Cytal® - Cytal® Wound Matrix 6-Layer, 5cm x 5cm
ACELL, INC.
2017-01-20
Cytal® - Cytal® Wound Matrix 3-Layer, 10cm x 15cm
ACELL, INC.
2017-01-20
Cytal® - Cytal® Wound Matrix 3-Layer, 7cm x 10cm
ACELL, INC.
2017-01-20
Cytal® - Cytal® Wound Matrix 3-Layer, 5cm x 5cm
ACELL, INC.
2017-01-20
Cytal® - Cytal® Wound Matrix 2-Layer, 10cm x 15cm
ACELL, INC.
2017-01-20
Cytal® - Cytal® Wound Matrix 2-Layer, 7cm x 10cm
ACELL, INC.
2017-01-20
Cytal® - Cytal® Wound Matrix 2-Layer, 5cm x 5cm
ACELL, INC.
2017-01-20
Cytal® - Cytal® Wound Matrix 1-Layer, 10cm x 15cm
ACELL, INC.
2017-01-20
Cytal® - Cytal® Wound Matrix 1-Layer, 7cm x 10cm
ACELL, INC.
2017-01-20
Cytal® - Cytal® Wound Matrix 1-Layer, 3cm x 7cm
ACELL, INC.
2017-01-20
Cytal® - Cytal® Wound Matrix 1-Layer, 3cm x 3.5cm
ACELL, INC.
2017-01-20
MicroMatrix® - MicroMatrix® UBM Standard Particulate, 1000mg
ACELL, INC.
2017-01-20
MicroMatrix® - MicroMatrix® UBM Fine Particulate, 200mg
ACELL, INC.
2017-01-20
MicroMatrix® - MicroMatrix® UBM Standard Particulate, 500mg
ACELL, INC.
2017-01-20
MicroMatrix® - MicroMatrix® UBM Standard Particulate, 200mg
ACELL, INC.
2017-01-20
MicroMatrix® - MicroMatrix® UBM Fine Particulate, 100mg
ACELL, INC.
2017-01-20
MicroMatrix® - MicroMatrix® UBM Standard Particulate, 100mg
ACELL, INC.
2017-01-20
MicroMatrix® - MicroMatrix® UBM Standard Particulate, 60mg
ACELL, INC.
2017-01-20
MicroMatrix® - MicroMatrix® UBM Standard Particulate, 30mg
ACELL, INC.
2017-01-20
MicroMatrix® - MicroMatrix® UBM Standard Particulate, 20mg
ACELL, INC.
2017-01-20
Cytal® - Cytal® Burn Matrix, 10cm x 15cm
ACELL, INC.
2017-01-20
Cytal® - Cytal® Burn Matrix, 7cm x 10cm
ACELL, INC.
2017-01-20
Cytal® - Cytal® Burn Matrix, 5cm x 5cm
ACELL, INC.
2017-01-20
Cytal® - Cytal® Wound Matrix 1-Layer 10 X 15 cm
ACELL, INC.
2017-01-10
Cytal® - Cytal® Wound Matrix 1-Layer 7 X 10 cm
ACELL, INC.
2017-01-10
Cytal® - Cytal® Wound Matrix 1-Layer 3 X 7 cm
ACELL, INC.
2017-01-10
Cytal® - Cytal® Wound Matrix 1-Layer 3 X 3 cm
ACELL, INC.
2017-01-10
Cytal® - Cytal® Wound Matrix 2-Layer 10 X 15 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 5 X 5 cm
ACELL, INC.
2017-01-10
Cytal® - Burn Matrix 5 X 5 cm
ACELL, INC.
2017-01-10
Cytal® - Burn Matrix 7 X 10 cm
ACELL, INC.
2017-01-10

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