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) (9) Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (KCT) (1)

Premarket Exempt

No Yes

Clear

Ez Trax - 00850006159109 Catalog Number :

Device Description : Base Assembly Aluminum (L)24 (W)12 (H)2

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Ez Trax - 00850006159116 Catalog Number : 053 BASE.ASSY.AL.24.12.2.4

Device Description : Base Assembly Aluminum (L)24 (W)12 (H)2.4

Device Class : 2

Duns Number: 080448429

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

Ez Trax - 00850006159123 Catalog Number : 055 BASE.ASSY.AL.24.12.4

Device Description : Base Assembly Aluminum (L)24 (W)12 (H)4

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Ez Trax - 00850006159130 Catalog Number : 060 INSERT.AL.24.12.2

Device Description : Insert Aluminum (L)24 (W)12 (H)2

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Ez Trax - 00850006159147 Catalog Number :

Device Description : Base Assembly Stainless Steel (L)24 (W)12 (H)2

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Ez Trax - 00850006159154 Catalog Number :

Device Description : Base Assembly Stainless Steel (L)24 (W)12 (H)4

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Ez Trax - 00850006159161 Catalog Number :

Device Description : Insert Stainless Steel (L)24 (W)12 (H)2

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Ez Trax - 00850006159178 Catalog Number :

Device Description : Lid Aluminum (L)24 (W)12

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850006159185 Catalog Number :

Device Description : Divider (H) 2.4 x (L) 02

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

EZ-TRAX™ - 00850006159192 Catalog Number :

Device Description : Divider (H) 2.4 x (L) 03

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

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