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

Mouthpiece, saliva ejector (DYN) (6) Evacuator, oral cavity (EHZ) (3) COTTON, ROLL (EFN) (1)

Premarket Exempt

No Yes

Clear

High Volume Evacuator Tips - 10732224000777 Catalog Number :

Device Description : High Volume Evacuator Tips, Non-Vented, White

Device Class :

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : DYN

Prescription Use : No

Device Count : 50

Surgical Aspirator Tips - 10732224000784 Catalog Number :

Device Description : Surgical Aspirator Tips, Blue–Small Tip, .0625 in, 0.16 cm

Device Class :

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : EHZ

Prescription Use : No

Device Count : 25

Surgical Aspirator Tips - 10732224000791 Catalog Number :

Device Description : Surgical Aspirator Tips, White–Standard Tip, 0.125”, 0.32 cm

Device Class :

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : EHZ

Prescription Use : No

Device Count : 25

Surgical Aspirator Tips - 10732224000807 Catalog Number :

Device Description : Surgical Aspirator Tips, Green–Large Tip, 0.25 in, 0.64 cm

Device Class :

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : EHZ

Prescription Use : No

Device Count : 25

Hygoformic™ Saliva Ejectors - 10732224000814 Catalog Number :

Device Description : Hygoformic Saliva Ejectors, White

Device Class :

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : DYN

Prescription Use : No

Device Count : 100

Hygoformic™ Saliva Ejectors - 10732224000821 Catalog Number :

Device Description : Hygoformic Saliva Ejectors Adapters

Device Class : 1

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : DYN

Prescription Use : No

Device Count : 10

Comfort Plus™ Premium Saliva Ejectors - 10732224000838 Catalog Number :

Device Description : Comfort Plus™ Premium Saliva Ejectors, White,Pink Bubble Gum Scented

Device Class :

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : DYN

Prescription Use : No

Device Count : 100

Comfort Plus™ Premium Saliva Ejectors - 10732224000845 Catalog Number :

Device Description : Comfort Plus™ Premium Saliva Ejectors, White,Green, Mint Scented

Device Class :

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : DYN

Prescription Use : No

Device Count : 100

Premium™ Saliva Ejectors - 10732224000852 Catalog Number :

Device Description : Premium™ Saliva Ejectors, Pink

Device Class :

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : DYN

Prescription Use : No

Device Count : 100

Crosstex Premium Cotton-Filled Sponges, Sterile - 10732224000883 Catalog Number :

Device Description : Cotton Filled Sponges,2 in x 2 in / 5.1 cm x 5.1 cm

Device Class :

Duns Number: 057728685

Premarket Exempt : No

Product Code : EFN

Prescription Use : No

Device Count : 200

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