SKYTRON LLC

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

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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

Light, surgical, ceiling mounted (FSY) (5) Light, surgical, floor standing (FSS) (5) Sterilizer, steam (FLE) (5)

Premarket Exempt

No Yes

Clear

Integrity Sterilizers - 10841736100018 Catalog Number : INTEGRITY 175

Device Description : Integrity 175 Vacuum/Gravity Steam Sterilizer, 17.5"W x 17.5"H x 26.5"D, Vertica Integrity 175 Vacuum/Gravity Steam Sterilizer, 17.5"W x 17.5"H x 26.5"D, Vertical Power Sliding Door w/ Foot Pedal Control, Water Ejector Vacuum System, House Steam, 120 Volt

Device Class : 2

Duns Number: 078375583

Premarket Exempt : No

Product Code : FLE

Prescription Use : Yes

Device Count : 1

Aurora Surgical Light Series - 10841736100025 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 : Yes

Device Count : 1

Aurora Surgical Light Series - 10841736100032 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 : Yes

Device Count : 1

Aurora Surgical Light Series - 10841736100049 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 : FSS, FSY

Prescription Use : Yes

Device Count : 1

Integrity Sterilizers - 10841736100056 Catalog Number : INTEGRITY 175SG

Device Description : Integrity 175SG Vacuum/Gravity Steam Sterilizer, 17.5"W x 17.5"H x 26.5"D, Verti Integrity 175SG Vacuum/Gravity Steam Sterilizer, 17.5"W x 17.5"H x 26.5"D, Vertical Power Sliding Door w/ Foot Pedal Control, Water Ejector Vacuum System, Steam Generator

Device Class : 2

Duns Number: 078375583

Premarket Exempt : No

Product Code : FLE

Prescription Use : Yes

Device Count : 1

Integrity Sterilizers - 10841736100063 Catalog Number : INTEGRITY 215

Device Description : Integrity 215 Vacuum/Gravity Steam Sterilizer, 21.5"W x 21.5"H x 38"D, Vertical Integrity 215 Vacuum/Gravity Steam Sterilizer, 21.5"W x 21.5"H x 38"D, Vertical Power Sliding Door w/ Foot Pedal Control, Water Ejector Vacuum System, House Steam

Device Class : 2

Duns Number: 078375583

Premarket Exempt : No

Product Code : FLE

Prescription Use : Yes

Device Count : 1

Aurora Surgical Light Series - 10841736100070 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 : Yes

Device Count : 1

Integrity Sterilizers - 10841736100087 Catalog Number : INTEGRITY 215SG

Device Description : Integrity 215SG Vacuum/Gravity Steam Sterilizer, 21.5"W x 21.5"H x 38"D, Vertica Integrity 215SG Vacuum/Gravity Steam Sterilizer, 21.5"W x 21.5"H x 38"D, Vertical Power Sliding Door w/ Foot Pedal Control, Water Ejector Vacuum System, Steam Generator

Device Class : 2

Duns Number: 078375583

Premarket Exempt : No

Product Code : FLE

Prescription Use : Yes

Device Count : 1

Integrity Sterilizers - 10841736100117 Catalog Number : INTEGRITY 270

Device Description : Integrity 270 Vacuum/Gravity Steam Sterilizer, 26.5"W x 37.5"H x 53"D, Power Doo Integrity 270 Vacuum/Gravity Steam Sterilizer, 26.5"W x 37.5"H x 53"D, Power Door Lock, Water Ejector Vacuum, House Steam

Device Class : 2

Duns Number: 078375583

Premarket Exempt : No

Product Code : FLE

Prescription Use : Yes

Device Count : 1

Nautilus Surgical Light Series - 10841736100124 Catalog Number :

Device Description : LED Surgical light

Device Class : 2

Duns Number: 078375583

Premarket Exempt : Yes

Product Code : FSY, FSS

Prescription Use : Yes

Device Count : 1

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