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 - 00842102100109 Catalog Number : 69800

Device Description : Davida Standard Neurosurgery Retractor and Handrest System

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 - 00842102100116 Catalog Number : 69802

Device Description : Davida Pattie Tray 3" x 6 3/4" (7.5 x 17cm)

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 - 00842102100123 Catalog Number : 69803

Device Description : 9" Davida Tapered Retractor Blade, 1/4" to 3/4" (6mm x 19mm)

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 - 00842102100130 Catalog Number :

Device Description : 9" Davida Tapered Retractor Blade, 5/32" to 5/8" (4mm x 16mm)

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 - 00842102100147 Catalog Number : 69805

Device Description : 9" Davida Tapered Retractor Blade, 1/8" to 1/2" (3mm x 12.5mm)

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 - 00842102100154 Catalog Number : 69806

Device Description : 9" Davida Tapered Retractor Blade, 3/32" to 3/8" (2.4mm x 9mm)

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 - 00842102100161 Catalog Number : 69807

Device Description : 9" Davida Tapered Retractor Blade, 1/16" to 1/4" (1.5mm x 6mm)

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 - 00842102100178 Catalog Number : 69013-TI

Device Description : Davida Handrest 10", 25cm - Titanium

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 - 00842102100185 Catalog Number : 69015-TI

Device Description : Davida Long Retractor Arm 9.5", 24cm - Titanium

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 - 00842102100192 Catalog Number : 69019-TI

Device Description : Davida Primary Bar 6", 15cm - Titanium

Device Class : 2

Duns Number: 047644935

Premarket Exempt : Yes

Product Code : GZT

Prescription Use : No

Device Count : 1

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