K1 MEDICAL TECHNOLOGIES, LLC

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) System, Test, Combs, Automated (KSM) (1)

Premarket Exempt

No Yes

Clear

Ez Trax - 00850006159000 Catalog Number :

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

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Ez Trax - 00850006159017 Catalog Number :

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

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Ez Trax - 00850006159024 Catalog Number :

Device Description : Base Assembly Aluminum (L)21 (W)12 (H)2

Device Class : 2

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : KSM

Prescription Use : No

Device Count : 1

Ez Trax - 00850006159031 Catalog Number : 047 BASE.ASSY.AL.21.12.2.4

Device Description : Base Assembly Aluminum (L)21 (W)12 (H)2.4

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Ez Trax - 00850006159048 Catalog Number : 049 BASE.ASSY.AL.21.12.4

Device Description : Base Assembly Aluminum (L)21 (W)12 (H)4

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Ez Trax - 00850006159055 Catalog Number :

Device Description : Insert Aluminum (L)21 (W)12 (H)2

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Ez Trax - 00850006159062 Catalog Number :

Device Description : Base Assembly Stainless Steel (L)21 (W)12 (H)2

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Ez Trax - 00850006159079 Catalog Number :

Device Description : Base Assembly Stainless Steel (L)21 (W)12 (H)4

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Ez Trax - 00850006159086 Catalog Number :

Device Description : Insert Stainless Steel (L)21 (W)12 (H)2

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Ez Trax - 00850006159093 Catalog Number :

Device Description : Lid Aluminum (L)21 (W)12

Device Class : 1

Duns Number: 080448429

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

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