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) (10)

Premarket Exempt

No Yes

Clear

Skytron - 10841736122881 Catalog Number : 5-010-21-1B

Device Description : 1/2 Inch X-RAY TOP HEAD SECTION 3600/6700

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736122898 Catalog Number : 5-010-21-2B

Device Description : 1/2 Inch X-RAY TOP BACK SECTION 3600/6700

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736122904 Catalog Number : 5-010-21-3B

Device Description : 1/2 Inch X-RAY TOP SEAT SECTION 6700

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736122911 Catalog Number : 5-010-21-3NCB

Device Description : 1/2 Inch THICK X-RAY TOP SEAT SECT W/ OUT CUT OUT 6700B

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736122928 Catalog Number : 5-010-21-4B

Device Description : 1/2 Inch X-RAY TOP FT/LEG SECTION 3600/6700

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736122935 Catalog Number : 5-010-21-B

Device Description : Radiographic top (6700 SERIES)

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736122942 Catalog Number : 5-010-21-BC

Device Description : CUSTOM 1/2 Inch THICK X-RAY TOP SET 6700B Inch NO CUT OUT Inch

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736122959 Catalog Number : 5-010-22-3B

Device Description : 1/2 Inch X-RAY TOP SEAT SECTION 3600

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736122966 Catalog Number : 5-010-22-3B C3

Device Description : 1/2 Inch X-RAY TOP SET 3600 Inch NO CUT OUT Inch

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736122973 Catalog Number : 5-010-22-3B-C

Device Description : 3600 SEAT SECTION X-RAY TOP SECTION WITHOUT CUTOUT

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

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