BURTON MEDICAL PRODUCTS CORPORATION

BURTON MEDICAL PRODUCTS CORPORATION

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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) (10)

Premarket Exempt

No

Clear

AIM 100 - 00858480006001 Catalog Number : 1017000-1

Device Description : LIGHT HEAD

Device Class : 2

Duns Number: 022382667

Premarket Exempt : No

Product Code : FSY

Prescription Use : No

Device Count : 1

AIM 100 - 00858480006018 Catalog Number : 1017800-2

Device Description : SINGLE CEILING MOUNT

Device Class : 2

Duns Number: 022382667

Premarket Exempt : No

Product Code : FSY

Prescription Use : No

Device Count : 1

AIM 100 - 00858480006025 Catalog Number : 1017444-2

Device Description : DOUBLE CEILING MOUNT

Device Class : 2

Duns Number: 022382667

Premarket Exempt : No

Product Code : FSY

Prescription Use : No

Device Count : 1

AIM 100 - 00858480006032 Catalog Number : 4000104

Device Description : SPRING ARM ASSEMBLY

Device Class : 2

Duns Number: 022382667

Premarket Exempt : No

Product Code : FSY

Prescription Use : No

Device Count : 1

AIM 100 - 00858480006049 Catalog Number : 6000184-2

Device Description : FLOOR BASE ASSEMBLY

Device Class : 2

Duns Number: 022382667

Premarket Exempt : No

Product Code : FSY

Prescription Use : No

Device Count : 1

AIM 100 - 00858480006056 Catalog Number : 1017067-2

Device Description : WALL MOUNT

Device Class : 2

Duns Number: 022382667

Premarket Exempt : No

Product Code : FSY

Prescription Use : No

Device Count : 1

AIM 200 - 00858480006063 Catalog Number : 6000154-1

Device Description : LIGHT HEAD

Device Class : 2

Duns Number: 022382667

Premarket Exempt : No

Product Code : FSY

Prescription Use : No

Device Count : 1

AIM 200 - 00858480006070 Catalog Number : 6000156-2

Device Description : DOUBLE CEILING MOUNT

Device Class : 2

Duns Number: 022382667

Premarket Exempt : No

Product Code : FSY

Prescription Use : No

Device Count : 1

AIM 200 - 00858480006087 Catalog Number : 6000185-2

Device Description : FLOOR BASE ASSEMBLY

Device Class : 2

Duns Number: 022382667

Premarket Exempt : No

Product Code : FSY

Prescription Use : No

Device Count : 1

AIM 200 - 00858480006094 Catalog Number : 6000158-2

Device Description : SINGLE CEILING MOUNT

Device Class : 2

Duns Number: 022382667

Premarket Exempt : No

Product Code : FSY

Prescription Use : No

Device Count : 1

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