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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

Light, Surgical, Ceiling Mounted (FSY) (7) Device, Medical Examination, Ac Powered (KZF) (3)

Premarket Exempt

No Yes

Clear

VISION EX5 - 00815871022255 Catalog Number :

Device Description : DRE Vision EX5, FLOOR MODEL

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : FSY

Prescription Use : No

Device Count : 1

VISION EX5 - 00815871022262 Catalog Number :

Device Description : DRE Vision EX5, SINGLE CEILING

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : FSY

Prescription Use : No

Device Count : 1

VISION EX5 - 00815871022279 Catalog Number :

Device Description : DRE Vision EX5, DUAL CEILING

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : FSY

Prescription Use : No

Device Count : 1

VISION EX5 - 00815871022286 Catalog Number :

Device Description : DRE Vision EX5, WALL MOUNT

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : FSY

Prescription Use : No

Device Count : 1

VISION EX5 - 00815871022293 Catalog Number :

Device Description : DRE Vision EX5, FLOOR MODEL

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : FSY

Prescription Use : No

Device Count : 1

VISION EX5 - 00815871022309 Catalog Number :

Device Description : DRE Vision EX5, SINGLE CEILING

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : FSY

Prescription Use : No

Device Count : 1

VISION EX5 - 00815871022316 Catalog Number :

Device Description : DRE Vision EX5, DUAL CEILING

Device Class : 2

Duns Number: 178440426

Premarket Exempt : No

Product Code : FSY

Prescription Use : No

Device Count : 1

Vista LED - 00815871022323 Catalog Number :

Device Description : DRE Vista LED, WALL

Device Class : 1

Duns Number: 178440426

Premarket Exempt : Yes

Product Code : KZF

Prescription Use : No

Device Count : 1

Vista LED - 00815871022330 Catalog Number :

Device Description : DRE Vista LED, FLOOR

Device Class : 1

Duns Number: 178440426

Premarket Exempt : Yes

Product Code : KZF

Prescription Use : No

Device Count : 1

Vista LED - 00815871022347 Catalog Number :

Device Description : DRE Vista LED, SINGLE CEILING

Device Class : 1

Duns Number: 178440426

Premarket Exempt : Yes

Product Code : KZF

Prescription Use : No

Device Count : 1

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