COASTAL LIFE TECHNOLOGIES, INC.

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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

Powered Laser Surgical Instrument (GEX) (10)

Premarket Exempt

No Yes

Clear

Surgimedics® - 00814716020388 Catalog Number :

Device Description : Fiber Optic Cable, Single-Use Disposable

Device Class : 2

Duns Number: 809254670

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Surgimedics® - 00814716020395 Catalog Number :

Device Description : Fiber Optic Cable, Single-Use Disposable

Device Class : 2

Duns Number: 809254670

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Surgimedics® - 00814716020401 Catalog Number :

Device Description : Fiber Optic Cable, Single-Use Disposable

Device Class : 2

Duns Number: 809254670

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Surgimedics® - 00814716020418 Catalog Number :

Device Description : Fiber Optic Cable, Single-Use Disposable

Device Class : 2

Duns Number: 809254670

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Surgimedics® - 00814716020425 Catalog Number :

Device Description : Fiber Optic Cable, Single-Use Disposable

Device Class : 2

Duns Number: 809254670

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Surgimedics® - 00814716020432 Catalog Number :

Device Description : Fiber Optic Cable, Single-Use Disposable

Device Class : 2

Duns Number: 809254670

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Surgimedics® - 00814716020449 Catalog Number :

Device Description : Fiber Optic Cable, Single-Use Disposable

Device Class : 2

Duns Number: 809254670

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Surgimedics® - 00814716020456 Catalog Number :

Device Description : Fiber Optic Cable, Single-Use Disposable

Device Class : 2

Duns Number: 809254670

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Surgimedics® - 00814716020463 Catalog Number :

Device Description : Fiber Optic Cable, Single-Use Disposable

Device Class : 2

Duns Number: 809254670

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Surgimedics® - 00814716020470 Catalog Number :

Device Description : Fiber Optic Cable, Single-Use Disposable

Device Class : 2

Duns Number: 809254670

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

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