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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, Fiberoptic (FST) (10)

Premarket Exempt

No Yes

Clear

MAXX LUXX LED - 00815871022033 Catalog Number :

Device Description : DUAL MAXX LUXX LED

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : FST

Prescription Use : No

Device Count : 1

MAXX LUXX LED - 00815871022040 Catalog Number :

Device Description : TRIO MAXX LUXX W/HD CAMERA

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : FST

Prescription Use : No

Device Count : 1

MAXX LUXX LED - 00815871022057 Catalog Number :

Device Description : TRIO MAXX LUXX W/HD CAMERA

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : FST

Prescription Use : No

Device Count : 1

MAXX LUXX LED - 00815871022064 Catalog Number :

Device Description : TRIO MAXX LUXX LED W/MON

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : FST

Prescription Use : No

Device Count : 1

MAXX LUXX LED - 00815871022071 Catalog Number :

Device Description : DUAL MAXX LUXX LED, VIDEO READY

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : FST

Prescription Use : No

Device Count : 1

MAXX LUXX LED - 00815871022088 Catalog Number :

Device Description : TRIO MAXX LUX LED

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : FST

Prescription Use : No

Device Count : 1

MAXX LUXX LED - 00815871022095 Catalog Number :

Device Description : SINGLE MAXX LUXX, DUAL MONITOR ARM

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : FST

Prescription Use : No

Device Count : 1

MAXX LUXX LED - 00815871022101 Catalog Number :

Device Description : DUAL MAXX LUXX LED, HD CAM & MONITOR ARM

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : FST

Prescription Use : No

Device Count : 1

MAXX LUXX LED - 00815871022118 Catalog Number :

Device Description : DUAL MAXX LUXX LED, HD CAM & MONITOR ARM

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : FST

Prescription Use : No

Device Count : 1

MAXX LUXX LED - 00815871022125 Catalog Number :

Device Description : DUAL MAXX LUXX, DUAL MONITOR ARM

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : FST

Prescription Use : No

Device Count : 1

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