FLEXBAR MACHINE 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

Retractor, Self-Retaining, For Neurosurgery (GZT) (10)

Premarket Exempt

No Yes

Clear

Davida Neurosurgery Retractor and Hand Stabilization Systems - 00842102100000 Catalog Number :

Device Description : Davida Large Instrument Holder 9" (22.9cm)

Device Class : 2

Duns Number: 047644935

Premarket Exempt : Yes

Product Code : GZT

Prescription Use : No

Device Count : 1

Davida Neurosurgery Retractor and Hand Stabilization Systems - 00842102100017 Catalog Number : 69012

Device Description : Davida Small Instrument Holder 9" (22.9cm)

Device Class : 2

Duns Number: 047644935

Premarket Exempt : Yes

Product Code : GZT

Prescription Use : No

Device Count : 1

Davida Neurosurgery Retractor and Hand Stabilization Systems - 00842102100024 Catalog Number : 69013

Device Description : Davida Handrest 10" (25cm)

Device Class : 2

Duns Number: 047644935

Premarket Exempt : Yes

Product Code : GZT

Prescription Use : No

Device Count : 1

Davida Neurosurgery Retractor and Hand Stabilization Systems - 00842102100031 Catalog Number : 69014

Device Description : Davida Short Retractor Arm 6.5" (16cm)

Device Class : 2

Duns Number: 047644935

Premarket Exempt : Yes

Product Code : GZT

Prescription Use : No

Device Count : 1

Davida Neurosurgery Retractor and Hand Stabilization Systems - 00842102100048 Catalog Number : 69015

Device Description : Davida Long Retractor Arm 9.5" (24cm)

Device Class : 2

Duns Number: 047644935

Premarket Exempt : Yes

Product Code : GZT

Prescription Use : No

Device Count : 1

Davida Neurosurgery Retractor and Hand Stabilization Systems - 00842102100055 Catalog Number :

Device Description : Davida Primary Bar 6" (15cm)

Device Class : 2

Duns Number: 047644935

Premarket Exempt : Yes

Product Code : GZT

Prescription Use : No

Device Count : 1

Davida Neurosurgery Retractor and Hand Stabilization Systems - 00842102100062 Catalog Number : 69020

Device Description : Davida Secondary Bar 12" (30cm)

Device Class : 2

Duns Number: 047644935

Premarket Exempt : Yes

Product Code : GZT

Prescription Use : No

Device Count : 1

Davida Neurosurgery Retractor and Hand Stabilization Systems - 00842102100079 Catalog Number : 69022

Device Description : Davida Floating Secondary Bar

Device Class : 2

Duns Number: 047644935

Premarket Exempt : Yes

Product Code : GZT

Prescription Use : No

Device Count : 1

Davida Neurosurgery Retractor and Hand Stabilization Systems - 00842102100086 Catalog Number : 69024

Device Description : Davida Instrument Holder Micro Holds up to 1/8" (3mm)

Device Class : 2

Duns Number: 047644935

Premarket Exempt : Yes

Product Code : GZT

Prescription Use : No

Device Count : 1

Davida Neurosurgery Retractor and Hand Stabilization Systems - 00842102100093 Catalog Number : 69035

Device Description : Davida Instrument Holder X-Large Holds up to 2" (5cm)

Device Class : 2

Duns Number: 047644935

Premarket Exempt : Yes

Product Code : GZT

Prescription Use : No

Device Count : 1

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