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® - 10381780355342 Catalog Number :

Device Description : BUDDE® Support Bracket Assembly

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

ContinuTrac™ - 10381780355359 Catalog Number : 438B1178

Device Description : BUDDE® Halo Ring

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

BUDDE® - 10381780355366 Catalog Number : 443A1000

Device Description : Radiolucent Halo Ring Assy

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

BUDDE® - 10381780355380 Catalog Number : 443A1004

Device Description : Radiolucent Halo Wrench

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

BUDDE® - 10381780355397 Catalog Number :

Device Description : BUDDE® Halo 12 inch (300 mm) Flex Arm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

BUDDE® - 10381780355410 Catalog Number :

Device Description : BUDDE® Halo Rod Support Clamp Assembly

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

BUDDE® - 10381780355427 Catalog Number :

Device Description : BUDDE® Halo 6 inch (150 mm) Flex Arm

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

BUDDE® - 10381780355441 Catalog Number :

Device Description : ROD COMPRESSION KNOB

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

BUDDE® - 10381780355465 Catalog Number :

Device Description : Compression Ball

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

BUDDE® - 10381780355472 Catalog Number :

Device Description : Locking Ring Knob

Device Class : 2

Duns Number: 963856096

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

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