K1 MEDICAL TECHNOLOGIES, LLC

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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) (10)

Premarket Exempt

No Yes

Clear

EZ-TRAX™ - 00850025473309 Catalog Number : 096 DIVIDER.1.72.10

Device Description : Divider (H) 1.72 x (L) 10

Device Class : 2

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : KCT

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850025473316 Catalog Number : 096 DIVIDER.1.72.11

Device Description : Divider (H) 1.72 x (L) 11

Device Class : 2

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : KCT

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850025473323 Catalog Number : 096 DIVIDER.1.72.12

Device Description : Divider (H) 1.72 x (L) 12

Device Class : 2

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : KCT

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850025473330 Catalog Number : 096 DIVIDER.1.72.13

Device Description : Divider (H) 1.72 x (L) 13

Device Class : 2

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : KCT

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850025473347 Catalog Number : 096 DIVIDER.1.72.14

Device Description : Divider (H) 1.72 x (L) 14

Device Class : 2

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : KCT

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850025473354 Catalog Number : 096 DIVIDER.1.72.15

Device Description : Divider (H) 1.72 x (L) 15

Device Class : 2

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : KCT

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850025473378 Catalog Number : 096 DIVIDER.1.72.17

Device Description : Divider (H) 1.72 x (L) 17

Device Class : 2

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : KCT

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850025473385 Catalog Number : 096 DIVIDER.1.72.18

Device Description : Divider (H) 1.72 x (L) 18

Device Class : 2

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : KCT

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850025473392 Catalog Number : 096 DIVIDER.1.72.19

Device Description : Divider (H) 1.72 x (L) 19

Device Class : 2

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : KCT

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850025473408 Catalog Number : 096 DIVIDER.1.72.20

Device Description : Divider (H) 1.72 x (L) 20

Device Class : 2

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : KCT

Prescription Use : No

Device Count : 1

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