CROSSTEX INTERNATIONAL, INC.

Address:621 Hurricane Shoals Rd NW Ste G,LAWRENCEVILLE,GA,30046,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Mask, surgical (FXX) (7) Indicator, physical/chemical sterilization process (JOJ) (2) Indicator, biological sterilization process (FRC) (1)

Premarket Exempt

No Yes

Clear

Crosstex International - 10732224120505 Catalog Number : GCSA

Device Description : Advantage Tie On Masks/BLUE

Device Class :

Duns Number: 057728685

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Crosstex International - 10732224120512 Catalog Number : GCABL

Device Description : Advantage earloop mask/BLUE

Device Class :

Duns Number: 057728685

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Crosstex International - 10732224120529 Catalog Number : GCAPK

Device Description : Advantage earloop mask/PINK

Device Class :

Duns Number: 057728685

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Crosstex International - 10732224120550 Catalog Number : GPLUSBL

Device Description : (ISOFLUID PLUS MASKS-BLUE)

Device Class :

Duns Number: 057728685

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Crosstex International - 10732224120567 Catalog Number : GPLUSKA

Device Description : (ISFLD PLUS KALEIDOSCOPE)

Device Class :

Duns Number: 057728685

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Crosstex International - 10732224120574 Catalog Number : GPLUSPK

Device Description : (ISOFLUID PLUS MASKS-PINK)

Device Class :

Duns Number: 057728685

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Crosstex International - 10732224120581 Catalog Number : GPLUSWHSF

Device Description : (XTEX SF ISO PLUS PURE-WH)

Device Class :

Duns Number: 057728685

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Chemical Indicator Pen - 10732224710010 Catalog Number :

Device Description : Steam Indicator Pen, to identify and monitor steam-processed items

Device Class : 2

Duns Number: 057728685

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

STEAMPlus™ Sterilization Integrator - 10732224710768 Catalog Number :

Device Description : Sterilization Integrator, 1000/PK

Device Class :

Duns Number: 057728685

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 100

Culture Media, 100/BX, 4 BX/CS - 10732224720064 Catalog Number :

Device Description : Culture Media, 100/BX, 4 BX/CS

Device Class : 2

Duns Number: 057728685

Premarket Exempt : No

Product Code : FRC

Prescription Use : No

Device Count : 100

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