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

Handpiece, belt and/or gear driven, dental (EFA) (3) Mask, surgical (FXX) (2) VARNISH, CAVITY (LBH) (2) COTTON, ROLL (EFN) (1) Sterilant, medical devices (MED) (1) Sterilization wrap containers, trays, cassettes & other accessories (KCT) (1)

Premarket Exempt

No Yes

Clear

Twist™ plus Oscillating Disposable Prophy Angles - 10732224000081 Catalog Number :

Device Description : Prophy Angles Tapered Brush

Device Class : 1

Duns Number: 057728685

Premarket Exempt : No

Product Code : EFA

Prescription Use : No

Device Count : 100

Crosstex International - 10732224000098 Catalog Number : GCITE

Device Description : (ISOFLUID MASK/TEAL)

Device Class :

Duns Number: 057728685

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Cotton Rolls - 10732224000104 Catalog Number :

Device Description : Cotton Rolls, Sterile

Device Class :

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : EFN

Prescription Use : No

Device Count : 2000

Crosstex International - 10732224000111 Catalog Number : JGLUT

Device Description : SaniGlut Glutaraldehyde

Device Class : 2

Duns Number: 057728685

Premarket Exempt : No

Product Code : MED

Prescription Use : No

Device Count : 1

Crosstex International - 10732224000180 Catalog Number : SCT8

Device Description : (SANI-ROLL 8"-100' ROLLS)

Device Class :

Duns Number: 057728685

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 100

Crosstex International - 10732224000326 Catalog Number : UFVBG

Device Description : Sparkle V Sodium Fluoride Varnish Bubble Gum

Device Class :

Duns Number: 057728685

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 120

Crosstex International - 10732224000333 Catalog Number : UFVM

Device Description : Sparkle V Sodium Fluoride Varnish Mint

Device Class :

Duns Number: 057728685

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 120

Sparkle™ EZ Contra Angle - 10732224000364 Catalog Number :

Device Description : Prophy Angle, Soft Cup, Purple

Device Class :

Duns Number: 057728685

Premarket Exempt : No

Product Code : EFA

Prescription Use : No

Device Count : 100

Sparkle™ EZ Contra Angle - 10732224000371 Catalog Number :

Device Description : Prophy Angle, Firm Cup, White

Device Class :

Duns Number: 057728685

Premarket Exempt : No

Product Code : EFA

Prescription Use : No

Device Count : 100

Le Petit Masque - 10732224000388 Catalog Number :

Device Description : Facemask, Pink

Device Class :

Duns Number: 057728685

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

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