SKYTRON LLC

Address:5085 Corporate Exchange Blvd SE,Grand Rapids,MI,49512,US

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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

TABLE, OPERATING-ROOM, AC-POWERED (FQO) (5) Light, Surgical, Accessories (FTA) (2) Camera, Surgical And Accessories (KQM) (1) Disinfector, Medical Devices (MEC) (1) Light, Surgical, Ceiling Mounted (FSY) (1) Light, Surgical, Floor Standing (FSS) (1)

Premarket Exempt

No Yes

Clear

Skytron - 10841736123086 Catalog Number : 5-010-28-B

Device Description : 1602SL X-RAY TOP SET

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736123093 Catalog Number : 5-010-29-D

Device Description : DIGITAL X-RAY TOP SET 3603

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736123109 Catalog Number : 3-040-33-1

Device Description : Disposable Face Mask, 12 per case.

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 12

Skytron - 10841736123116 Catalog Number : 3-040-22

Device Description : Head & chin straps, 12 ea. per case

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 12

Skytron - 10841736123154 Catalog Number : 5-010-30-D

Device Description : DIGITAL X-RAY TOP SET 3503

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Lumos Surgical Light Series - 10841736123161 Catalog Number :

Device Description : LED Surgical Light with center focus with optional camera capability

Device Class : 2

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FSY, FSS

Prescription Use : No

Device Count : 1

Precision HD Camera for Lumos - 10841736123178 Catalog Number :

Device Description : Precision HD Camera for Lumos series light

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : KQM

Prescription Use : No

Device Count : 1

Center Focus Handle - 10841736123185 Catalog Number :

Device Description : Center Focus Handle with Intensity Control for Lumos Series

Device Class : 2

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FTA

Prescription Use : No

Device Count : 1

Camera Cover - 10841736123192 Catalog Number :

Device Description : Sterilizable Camera Cover with intensity control for Lumos Series

Device Class : 2

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FTA

Prescription Use : No

Device Count : 1

Sterling C2000 - 10841736123208 Catalog Number :

Device Description : C2000 4 Level Instrument Rack

Device Class : 2

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : Yes

Device Count : 1

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