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 - 10841736122782 Catalog Number : 5-010-16-3B

Device Description : 3/8 Inch SEAT SECTION 3500 SERIAL No 1996-067 AND LATER

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736122799 Catalog Number : 5-010-16-B

Device Description : 3/8 Inch X-RAY TOP SET 3500 Serial No 1996-067 AND LATER

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736122805 Catalog Number : 5-010-17-B

Device Description : 1/2 Inch X-RAY TOP SET 3100/A WITH HD STANDOFFS

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736122812 Catalog Number : 5-010-18-4B

Device Description : 3/8 Inch X-RAY FT./LEG SECTION 6600

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736122829 Catalog Number : 5-010-18-B

Device Description : 3/8 Inch X-RAY TOP SET 6600

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736122836 Catalog Number : 5-010-19-1

Device Description : 3/8 Inch X-RAY TOP SET 1700 WITHOUT STAND OFFS OR VELCRO

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736122843 Catalog Number : 5-010-19-2B

Device Description : 3/8 Inch X-RAY BACK SECTION 1700

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736122850 Catalog Number : 5-010-19-3B

Device Description : 3/8 Inch X-RAY SEAT SECTION 1700

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736122867 Catalog Number : 5-010-19-4B

Device Description : 3/8 Inch X-RAY FOOT/LEG SECTION 1700

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

Skytron - 10841736122874 Catalog Number : 5-010-19-B

Device Description : Radiographic top (1700)

Device Class : 1

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : No

Device Count : 1

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