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) (7) SURGICAL TABLE CUSHION (LWG) (2)

Premarket Exempt

No Yes

Clear

Skytron - 10841736123314 Catalog Number : 4-030-04-2S

Device Description : 2 Inch Sof-Pad Split Leg Foot Rest

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

Skytron - 10841736123321 Catalog Number : 2-060-06-P

Device Description : Singer Starr Stacker Bariatric pad set

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : No

Device Count : 1

Skytron - 10841736123338 Catalog Number : 4-090-16

Device Description : Flex Fit 2

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736123345 Catalog Number : 4-090-17

Device Description : Versa Fit (does not include Boots)

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736123352 Catalog Number : 4-090-17-1

Device Description : Versa Fit Standard Boot (sold as a pair)

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736123369 Catalog Number : 4-090-17-2

Device Description : Versa Fit Elite Boot (sold as a pair)

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736123376 Catalog Number : 4-090-17-3

Device Description : Versa Fit Bariatric Boot (sold as a pair)

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736123383 Catalog Number : 4VSTH-CP1

Device Description : HD/MD VST clamp w/single Skytrack, Freedom

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736123390 Catalog Number : 4VSTH-CP2

Device Description : HD/MD VST clamp w/double Skytrack, Freedom

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

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