CROSSTEX INTERNATIONAL, INC.

Address:534 VINE STREET,SHARON,PA,16146,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) (3) Sterilization wrap containers, trays, cassettes & other accessories (KCT) (3) DRESS, SURGICAL (FYE) (2) CONTAINER, LIQUID MEDICATION, GRADUATED (KYW) (1) Unit, operative dental, accessories (NRD) (1)

Premarket Exempt

No Yes

Clear

Nylon Self-seal Sterilization Pouch - 10732224733606 Catalog Number :

Device Description : Nylon Self-seal Sterilization Pouch

Device Class : 2

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : KCT

Prescription Use : No

Device Count : 100

Self-Sealing Sterilization Bag - 30732224001129 Catalog Number :

Device Description : Self-Sealing Sterilization Bag,2.5 in x 1.5 in x 10.5 in (6.5 cm x 4 cm x 27 cm)

Device Class :

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : KCT

Prescription Use : No

Device Count : 1000

Self-Sealing Sterilization Bag - 30732224001136 Catalog Number :

Device Description : Self-Sealing Sterilization Bag, 2.5 in x 1.5 in x 8.75 in (6.5 cm x 4 cm x 22 cm)

Device Class :

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : KCT

Prescription Use : No

Device Count : 1000

Medicine Mixing Cups - 30732224002522 Catalog Number :

Device Description : Medicine Mixing Cups

Device Class :

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : KYW

Prescription Use : No

Device Count : 10

Non-Woven Headrest covers - 30732224003901 Catalog Number :

Device Description : Non-Woven Headrest Covers,Standard, 10 in x 10 in, 25 x 25 cm, Blue

Device Class : 1

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : KME

Prescription Use : No

Device Count : 500

Non-Woven Headrest covers - 30732224003918 Catalog Number :

Device Description : Non-Woven 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

Non-Woven Headrest covers - 30732224003925 Catalog Number :

Device Description : Non-Woven 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

Sani Vac Evacuation System Cleaner - 50732224000140 Catalog Number :

Device Description : Evacuation System Cleaner

Device Class : 1

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 80

Crosstex Disposable Face Shields - 50732224000935 Catalog Number :

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

Device Class : 1

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : FYE

Prescription Use : No

Device Count : 72

Crosstex Disposable Face Shields - 50732224000959 Catalog Number :

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

Device Class : 1

Duns Number: 057728685

Premarket Exempt : Yes

Product Code : FYE

Prescription Use : No

Device Count : 72

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