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

COTTON, ROLL (EFN) (5) CHAIR, DENTAL, WITHOUT OPERATIVE UNIT (NRU) (3) DRESS, SURGICAL (FYE) (2)

Premarket Exempt

Yes No

Clear

Barrier Film - 10732224000890 Catalog Number :

Device Description : Barrier Film with Finger-Lift Edge, 4” x 6” / 10 x 15 cm (Clear)

Device Class : 1

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : NRU

Prescription Use : No

Device Count : 1

Barrier Film - 10732224000906 Catalog Number :

Device Description : Barrier Film with Finger-Lift Edge, 4” x 6” / 10 x 15 cm (Blue)

Device Class : 1

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : NRU

Prescription Use : No

Device Count : 1

Crosstex Barrier Film - 10732224000913 Catalog Number :

Device Description : Barrier Fim, Pink

Device Class : 1

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : NRU

Prescription Use : No

Device Count : 1

Crosstex Disposable Face Shields - 10732224000920 Catalog Number :

Device Description : Face Shield, 3/4 Length Clear (7")

Device Class :

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : FYE

Prescription Use : No

Device Count : 24

Crosstex Disposable Face Shields - 10732224000944 Catalog Number :

Device Description : Face Shield, Full Length (9") Clear

Device Class :

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : FYE

Prescription Use : No

Device Count : 18

Crosstex Ultra-Gauze Non-Woven Sponges Non-Sterile, 4-Ply - 10732224001071 Catalog Number :

Device Description : Non-Woven Sponges, 2 in x 2 in / 5.1 cm x 5.1 cm

Device Class :

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : EFN

Prescription Use : No

Device Count : 200

Crosstex Ultra-Gauze Non-Woven Sponges Non-Sterile, 4-Ply - 10732224001088 Catalog Number :

Device Description : Non-Woven Sponges, 2 in x 2 in / 5.1 cm x 5.1 cm

Device Class :

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : EFN

Prescription Use : No

Device Count : 200

Ultra Gauze Non-Woven Sponges 4 Ply, Non-Sterile - 10732224001095 Catalog Number :

Device Description : Non-Woven Sponges,3"x3" / 7.62x7.62 cm- 40 GR WT

Device Class :

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : EFN

Prescription Use : No

Device Count : 200

Crosstex Ultra Gauze Non-Woven Sponges, 4 Ply, Non-Sterile - 10732224001101 Catalog Number :

Device Description : Non-Woven Sponges 4 Ply, Non-Sterile, 4"x4" / 10x10 cm- 40 GR WT

Device Class :

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : EFN

Prescription Use : No

Device Count : 200

Crosstex Advantage Plus Non-Woven Sponges Non-Sterile, 4-Ply - 10732224001118 Catalog Number :

Device Description : Non-Woven Sponges, 2 in x 2 in / 5.1 cm x 5.1 cm

Device Class :

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : EFN

Prescription Use : No

Device Count : 200

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