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

Tray, Surgical, Instrument (FSM) (6) Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (KCT) (4)

Premarket Exempt

No Yes

Clear

EZ-TRAX™ - 00850006159307 Catalog Number :

Device Description : Divider (H) 2.4 x (L) 14

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850006159314 Catalog Number :

Device Description : Divider (H) 2.4 x (L) 15

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850006159321 Catalog Number : 068 DIVIDER.2.4.16

Device Description : Divider (H) 2.4 x (L) 16

Device Class : 2

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : KCT

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850006159338 Catalog Number : 068 DIVIDER.2.4.17

Device Description : Divider (H) 2.4 x (L) 17

Device Class : 2

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : KCT

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850006159345 Catalog Number : 068 DIVIDER.2.4.18

Device Description : Divider (H) 2.4 x (L) 18

Device Class : 2

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : KCT

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850006159352 Catalog Number : 068 DIVIDER.2.4.19

Device Description : Divider (H) 2.4 x (L) 19

Device Class : 2

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : KCT

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850006159369 Catalog Number :

Device Description : Divider (H) 2.4 x (L) 20

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850006159383 Catalog Number :

Device Description : Bracket Silicone (H) 2.4 Standard Round Dia. 2mm

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850006159413 Catalog Number :

Device Description : Bracket Silicone (H) 2.4 Standard Round Dia. .250

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850006159437 Catalog Number :

Device Description : Bracket Silicone (H) 2.4 Standard Round Dia. .375

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

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