FDA.reportPublic FDA data

DEMETECH CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10645843003063934DEMETECH CORP.1N2026-01-015980 Miami Lakes Drive Miami Lakes FL US 33014

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
30652927684422DemeSILK - Nonabsorbable Silk Surgical Suture3058241048info@demetech.us
30652927776882DemeDIOX - Absorbable Polydioxanone Surgical Suture3058241048info@demetech.us
30652927777513DemeSILK - Nonabsorbable Silk Surgical Suture3058241048info@demetech.us

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
577681611771200K201479DemeMASKFXX2020-07-24
577681102679360K191361DemeDIOX Barbed Absorbable Surgical SutureNEW2019-11-07
577681130205140K190777DemeTECH DemeFORCE Nonabsorbable Surgical SutureGAT2019-07-31
577681903886908K181582DemeTECH DemeDIOX absorbable surgical sutureNEW2018-08-27
577681323798094K181578DemeTECH PTFE Nonabsorbable Surgical SutureNBY2018-10-11
577682052185467K141007DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTUREGAQ2014-09-25
577681436328531K130083DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTUREGAM2013-07-17
577681383660967K123940DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTUREGAM2014-05-30
577681599878587K082097DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURENEW2010-01-08
577681740119731K072930DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUTGAL2008-04-30
577681616270018K060018TRULENE MESHFTL2006-07-26
577681995503269K043539DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLESGAM2005-04-06
577681637696881K043330POLYPROPILENE SURGICAL SUTURESGAW2005-05-16
577681238936151K023030DEMETECH POLYESTER NONABSORBABLE SUTUREGAT2003-06-18
577681241537604K023029DEMETECH SILK NONABSORBABLE SUTUREGAP2002-11-25
577681780338658K023028DEMETECH NYLON NONABSORBABLE SUTUREGAR2003-06-18
577681065546781
577681424429748
577681831831129
577681114215952
577681305862716
577681338279714
577681351081382
577681726728991
577681735500436
577681787618322
577682019078303

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NEW32019-11-07
GAM32014-05-30
GAT22019-07-31
FXX12020-07-24
NBY12018-10-11
GAQ12014-09-25
GAL12008-04-30
FTL12006-07-26
GAW12005-05-16
GAR12003-06-18
GAP12002-11-25

PMN#

GUDID#

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