FDA.reportPublic FDA data

CellEra, LLC

Matched from indexed company URL: CELLERA LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30075947343007594734CellEra, LLC1N2026-01-011045 Reed Road Unit C Monroe OH US 45050

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
00850005565185Vitale - Vitale Collagen Powder, 1 gram/packet, 10 packets/box, 10 boxes/case, 8 cases/overpack800-892-2391sales@cellerallc.com
00850005565376Vitale - "Vitale Collage Dressings, 1"" x 1"", 10/box, 10 boxes/case, 8 cases/overpack"800-892-2391sales@cellerallc.com
00850005565406Vitale - "Vitale Collagen Dressings, 2"" x 2"", 10/box, 10 boxes/case, 8 cases/overpack"800-892-2391sales@cellerallc.com
00850005565420Vitale - "Vitale Collagen Dressings, 4"" x 4"", 10/box, 10 boxes/case, 4 cases/overpack"800-892-2391sales@cellerallc.com
00850065122076Vitale - "Silicone Post-Op Composite Dressings 4""x 8"", 1/pouch, 30/box, 10 boxes/case"800-892-2391sales@cellerallc.com
00850065122083Vitale - Silicone Post-Op Composite Dressings 4"x 8", 1/pouch, 30/box, 10 boxes/case800-892-2391sales@cellerallc.com
00850065122090Vitale - "Vitale Collagen Dressings, 7"" x 7"", 10/box, 10 boxes/case"800-892-2391sales@cellerallc.com
B492301500Glucertain - Glucertain Blood Glucose Test Strips, 25/vial, 2 vials/box, 260 boxes/case800-892-2391sales@cellerallc.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1029861179175420K242985CollOvine™ Wound DressingKGN2025-06-20
1029861940088799K210987IRRIGO Wound Wash Jet SystemFQH2022-05-31
1029861803929980K170077LUOFUCON Silicone Ag Foam Dressing with BorderFRO2017-03-30
1029861969210210K160022LUOFUCON Silicone Ag foam dressingFRO2016-08-17
1029861814419454K150758
1029861718475687K143335Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC)FRO2015-06-01
1029862041113226K112901EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE SYSTEMLFR2011-12-23
1029861667447360K060832RETRO-TECH DRESSINGFRO2007-03-13
1029861304349307K040211MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSINGKGN2004-02-27
1029861298105514K030921COLLAGEN TOPICAL WOUND DRESSINGKGN2003-05-15
1029861642190089
1029861004765817
1029861101897840
1029861126637933
1029861537465065
1029861751580238

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FRO42017-03-30
KGN32025-06-20
FQH12022-05-31
LFR12011-12-23

PMN#

GUDID#

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