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) (5) Tray, Surgical, Instrument (FSM) (5)

Premarket Exempt

Yes No

Clear

EZ-TRAX™ - 00850006159581 Catalog Number : 101 POST.1PC.2.0

Device Description : Post 1 PC Size 2

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850006159758 Catalog Number : 067.00 DIVIDER.2.03

Device Description : Divider (H) 2 x (L) 03

Device Class : 2

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : KCT

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850006159789 Catalog Number : 097 BRACKET-AL-H2.0-SZ02-P001

Device Description : BRACKET (H) 2 x (L) 02 x (P) 001

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850006159796 Catalog Number : 098 BRACKET-AL-H2.0-SZ02-P002

Device Description : BRACKET (H) 2 x (L) 02 x (P) 002

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850006159802 Catalog Number : 099 BRACKET-AL-H2.0-SZ10-P001

Device Description : BRACKET (H) 2 x (L) 10 x (P) 001

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850006159819 Catalog Number : 100 BRACKET-AL-H2.0-SZ10-P002

Device Description : BRACKET (H) 2 x (L) 10 x (P) 002

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850006159826 Catalog Number : 067.00 DIVIDER.2.04

Device Description : Divider (H) 2 x (L) 04

Device Class : 2

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : KCT

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850006159833 Catalog Number : 067.00 DIVIDER.2.08

Device Description : Divider (H) 2 x (L) 08

Device Class : 2

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : KCT

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850006159840 Catalog Number : 067.00 DIVIDER.2.10

Device Description : Divider (H) 2 x (L) 10

Device Class : 2

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : KCT

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850006159857 Catalog Number : 067.00 DIVIDER.2.02

Device Description : Divider (H) 2 x (L) 02

Device Class : 2

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : KCT

Prescription Use : No

Device Count : 1

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