INTEGRA LIFESCIENCES CORPORATION

Address:4900 CHARLEMAR DR.,,CINCINNATI,OH,45227,US

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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

RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY (GZT) (10)

Premarket Exempt

No Yes

Clear

BUDDE® - 10381780355236 Catalog Number :

Device Description : SPLIT PIVOTING HALO

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

BUDDE® - 10381780355243 Catalog Number :

Device Description : LEFT HAND BRACKET ASSEMBLY

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

BUDDE® - 10381780355250 Catalog Number :

Device Description : RIGHT HAND BRACKET ASSEMBLY

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

BUDDE® - 10381780355267 Catalog Number :

Device Description : SUPPORT ROD

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

BUDDE® - 10381780355274 Catalog Number :

Device Description : BUDDE® Halo Compression Ball (5/16”)

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

BUDDE® - 10381780355281 Catalog Number :

Device Description : BUDDE® Halo 12” Support Rod (5/16”)

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

BUDDE® - 10381780355298 Catalog Number :

Device Description : SAMY™ Vascular Retractor Blade – Short 3.6”

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

BUDDE® - 10381780355304 Catalog Number :

Device Description : SAMY™ Vascular Retractor Blade – Long 4.6"

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

BUDDE® - 10381780355328 Catalog Number :

Device Description : Halo Retractor Arm Knob

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

BUDDE® - 10381780355335 Catalog Number :

Device Description : BUDDE® Halo Washer

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

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