ACELL, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30059207063005920706ACELL, INC.1N2026-01-016640 Eli Whitney Dr Ste 200 Columbia MD US 21046
30045552983004555298ACell, Inc.1N2020-04-253589 Sagamore Parkway North, Suite 220 Lafayette IN US 47904
30059207063005920706ACELL, INC.1Y2020-04-256640 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 GUDIDProductPhoneEmail
00386190001820Cytal® - Cytal® Wound Matrix 3-Layer, 16cm x 25cm+1(800)826-2926customerservice@acell.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2890361689470698K241724Cytal® Wound Matrix; Cytal® Burn MatrixKGN2024-07-11
2890361342728165K241706MicroMatrix® UBM ParticulateKGN2024-07-11
2890361146857950K230980MicroMatrix® FlexKGN2023-09-22
1049801130982375K192725Cytal Wound Matrix 3-LayerKGN2019-10-25
2890361467881936K192725Cytal Wound Matrix 3-LayerKGN2019-10-25
2890361249324040K191734MatriStem UBM Pericardial PatchPSQ2019-11-22
1049802047586850K191734MatriStem UBM Pericardial PatchPSQ2019-11-22
2890361027869255K182259Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalFTM2019-02-07
910341863832736K182259Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalFTM2019-02-07
1049801863832736K182259Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalFTM2019-02-07
2890361446841775K172399MicroMatrixKGN2017-10-06
1049801776880268K172399MicroMatrixKGN2017-10-06
910341776880268K172399MicroMatrixKGN2017-10-06
1049801871682762K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendFTM2017-06-08
910341871682762K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendFTM2017-06-08
2890361938214924K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendFTM2017-06-08
910341171975287K162554Gentrix Surgical MatrixFTM2016-10-21
1049801171975287K162554Gentrix Surgical MatrixFTM2016-10-21
910341459315567K153754MicroMatrixKGN2016-03-14
1049801459315567K153754MicroMatrixKGN2016-03-14
910341494906811K152721Cytal Wound MatrixKGN2015-12-08
1049801494906811K152721Cytal Wound MatrixKGN2015-12-08
2890362011716896K152721Cytal Wound MatrixKGN2015-12-08
2890361447220566K150985Medihoney Wound GelFRO2015-11-19
2890361324713683K110546MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEYFRO2011-07-27
2890361259386103K101793MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEYFRO2011-02-22
2890361355020156K080315DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEYFRO2008-04-23
2890361775000217K072956MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEYFRO2007-11-07
2890361112830902K053095HONEY ALGINATE DRESSINGFRO2007-07-12
1049801199573196K040621ACELL UBM SURGICAL MESHFTM2004-04-14
1049801172209451
1049801183133095
1049801230761454
1049801496196071
1049801607608323
1049801890179788
1049801999139331
2890361886910461

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KGN132024-07-11
FTM92019-02-07
FRO62015-11-19
PSQ22019-11-22

NDC#

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 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

Doxycycline

Acella Pharmaceuticals, LLC

Doxycycline hyclate

Naproxen

Acella Pharmaceuticals, LLC

Naproxen

PMN#

Applications#

GUDID#

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