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

BEDDING, DISPOSABLE, MEDICAL (KME) (6) VARNISH, CAVITY (LBH) (2) Unit, operative dental, accessories (NRD) (1)

Premarket Exempt

No Yes

Clear

Polycoated Headrest covers - 50732224002687 Catalog Number :

Device Description : Polycoated Headrest covers,Standard, 10 in x 10 in, 25 x 25 cm, White

Device Class : 1

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : KME

Prescription Use : No

Device Count : 500

Polycoated Headrest covers - 50732224002694 Catalog Number :

Device Description : Polycoated Headrest covers, Dusty Rose, 10 in x 10 in, 25 x 25 cm

Device Class : 1

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : KME

Prescription Use : No

Device Count : 500

Polycoated Headrest covers - 50732224002700 Catalog Number :

Device Description : Polycoated Headrest covers,Standard, 10 in x 10 in, 25 x 25 cm, Lavender

Device Class : 1

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : KME

Prescription Use : No

Device Count : 500

Polycoated Headrest covers - 50732224002717 Catalog Number :

Device Description : Polycoated Headrest covers, Extra Jumbo, 11.5 in X15 in, 29x38cm, White

Device Class : 1

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : KME

Prescription Use : No

Device Count : 500

Non-Woven Headrest covers - 50732224003936 Catalog Number :

Device Description : No-Woven Headrest covers, Extra Large, 10 in X 13 in, White

Device Class : 1

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : KME

Prescription Use : No

Device Count : 500

Non-Woven Headrest covers - 50732224003950 Catalog Number :

Device Description : Non-Woven Headrest covers,Extra Large,10 in X 13 in, White

Device Class : 1

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : KME

Prescription Use : No

Device Count : 500

Sani Vac Evacuation System Cleaner - 50732224109508 Catalog Number :

Device Description : Evacuation System Cleaner

Device Class : 1

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 4

Crosstex International - D682UFVPM2N Catalog Number : UFVPM

Device Description : ProGuard Sodium Fluoride Varnish Mint

Device Class :

Duns Number: 057728685

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 50

Crosstex International - D682UFVPML21 Catalog Number : UFVPML

Device Description : ProGuard Sodium Fluoride Varnish Melon

Device Class :

Duns Number: 057728685

Premarket Exempt : No

Product Code : LBH

Prescription Use : No

Device Count : 50

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