FLEXBAR MACHINE CORPORATION

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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) (9) Laparoscope, General & Plastic Surgery (GCJ) (1)

Premarket Exempt

No Yes

Clear

Davida Neurosurgery Retractor and Hand Stabilization Systems - 00842102100208 Catalog Number : 69020-TI

Device Description : Davida Secondary Bar 12", 30cm - 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 - 00842102100215 Catalog Number : 69022-TI

Device Description : Davida Floating Secondary Bar - 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 - 00842102100222 Catalog Number : 69803-TI

Device Description : 9" Titanium 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 - 00842102100239 Catalog Number : 69804-TI

Device Description : 9" Titanium 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 - 00842102100246 Catalog Number : 69805-TI

Device Description : 9" Titanium 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 - 00842102100253 Catalog Number : 69806-TI

Device Description : 9" Titanium 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 - 00842102100260 Catalog Number : 69807-TI

Device Description : 9" Titanium 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 - 00842102100277 Catalog Number : 69801

Device Description : Davida Univ. Retractor Case

Device Class : 2

Duns Number: 047644935

Premarket Exempt : Yes

Product Code : GZT

Prescription Use : No

Device Count : 1

Mediflex 3.5mm Laparoscopic Instruments - 00842102100284 Catalog Number : 92300

Device Description : Cvd Metz Scis, w/ Flush Port & non-Locking Handle, 3.5mmx26cm

Device Class : 2

Duns Number: 047644935

Premarket Exempt : No

Product Code : GCJ

Prescription Use : No

Device Count : 1

Davida Neurosurgery Retractor and Hand Stabilization Systems - 00842102100291 Catalog Number : 69810

Device Description : Davida Deluxe Neurosurgery Retractor and Handrest System

Device Class : 2

Duns Number: 047644935

Premarket Exempt : Yes

Product Code : GZT

Prescription Use : No

Device Count : 1

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