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PRESTIGE AMERITECH

Matched from indexed company URL: Prestige Ameritech

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30050224833005022483PRESTIGE AMERITECH1Y2026-01-017201 Iron Horse Blvd. North Richland Hills TX US 76180

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
00811220034795PremierPro™ - PremierPro™ by MedSource TrueSafe Comfort® Blood Control Safety IV Catheter, 20G x 1in, 1 each1-855-531-7699udi@s2s-global.com
00818566011541PremierPro - PremierPro Disposable Lab Coats Knit Collar and Cuffs, Blue, Large, 10/bg1-855-531-7699info@s2s-global.com
00818566011558PremierPro - PremierPro Disposable Lab Coats Knit Collar and Cuffs, Blue, X-Large, 10/bg1-855-531-7699info@s2s-global.com
00818566016454PremierPro - Earloop Procedure Mask, Anti-Fog Foam & Visor, ASTM 3, Sea Blue1-855-531-7699udi@s2s-global.com
00818566019783PremierPro - Earloop Procedure Mask, ASTM Level 1, Blue1-855-531-7699udi@s2s-global.com
00852212003788PrestigePro - Earloop Mask w/Visor & Anti-Fog Foam, Blue, ASTM Level 318664018972orders@prestigeam.com
00852212003795PrestigePro - Earloop Mask, Blue, ASTM Level 118664018972orders@prestigeam.com
00852212003801ProGear - Bottom Gap Shield Mask, ASTM Level 3, Earloop Blue (USA)18664018972orders@prestigeam.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
647161030905516K984558DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)KGO1999-02-26
647161869329883K231741ProGear® Surgical Mask with Oxafence®, Model AV82030OUK2024-09-05
647161088774181K222225Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)LZA2022-11-11
647161496061017K220118Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination GlovesLZA2022-05-12
647161367642252K182600Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)LZA2018-11-30
647161314116734K171873Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy DrugsLZA2017-11-15
647161703581789K171162Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap ShieldFXX2017-08-15
647161371003429K170136Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy DrugsLZA2017-08-25
647161163846447K160100Prestige Ameritech Pediatric/Child’s Face maskOXZ2016-10-07
647161150472897K152561Communicator Surgical Facemask with Clear WindowFXX2016-06-03
647161060487985K151694Gammex PI Hybrid Surgical GlovesKGO2016-03-09
647161339788596K103714ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERAKGO2011-07-07
647161733396123K102096POWDER FREE NITRILE EXAMINATION GLOVES, BLUELZA2010-10-04
647161908335116K102092PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIESMSH2010-10-06
647161701112509K071746DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVESKGO2007-12-13
647161950361439K061716PRESTIGE AMERITECH FACE MASKFXX2006-08-14
647161040124979K051793ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING (CONTAINING GLYCERINE)KGO2005-08-17
647161430295377K000295ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)KGO2000-02-16
647161044290619
647161077065453
647161267928164
647161318730128
647161557468862
647161632602527
647161760844949

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LZA62022-11-11
KGO62016-03-09
FXX32017-08-15
OUK12024-09-05
OXZ12016-10-07
MSH12010-10-06

PMN#

GUDID#

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