CASE MEDICAL INC.

Address:50 West St.,Bloomfield,NJ,07003,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

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (KCT) (4)

Premarket Exempt

No Yes

Clear

Case Medical - 00653159011337 Catalog Number : ENDOQ1T6

Device Description : ACCESSORY TRAY FOR 3/4 SIZE ENDOQ1T456 SYSTEM

Device Class : 2

Duns Number: 053057972

Premarket Exempt : Yes

Product Code : KCT

Prescription Use : No

Device Count : 1

Case Medical - 00653159011344 Catalog Number : 000135

Device Description : SILICONE MAT FULL SIZE (20.3"X9.5")

Device Class : 2

Duns Number: 053057972

Premarket Exempt : Yes

Product Code : KCT

Prescription Use : No

Device Count : 1

Case Medical - 00653159011375 Catalog Number : YNB1009O21H

Device Description : DAVINCI XI ENDOSCOPE TRAY (25.5''X15.5''X4.0'')

Device Class : 2

Duns Number: 053057972

Premarket Exempt : Yes

Product Code : KCT

Prescription Use : No

Device Count : 1

Case Medical - 00653159011382 Catalog Number : APC10

Device Description : APC10 INSERT BOX W/HINGE ASSEMBLY (4.1''"X1.8"X2.5"H)

Device Class : 2

Duns Number: 053057972

Premarket Exempt : Yes

Product Code : KCT

Prescription Use : No

Device Count : 1

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