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

Laparoscope, General & Plastic Surgery (GCJ) (8) Retractor, Self-Retaining, For Neurosurgery (GZT) (2)

Premarket Exempt

No Yes

Clear

Davida Neurosurgery Retractor and Hand Stabilization Systems - 00842102100307 Catalog Number : 69800-TI

Device Description : Davida Titanium Neurosurgery Retractor & 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 - 00842102100314 Catalog Number : 69810-TI

Device Description : Davida Deluxe Titanium Neuro Retractor & Handrest System

Device Class : 2

Duns Number: 047644935

Premarket Exempt : Yes

Product Code : GZT

Prescription Use : No

Device Count : 1

Mediflex 3.5mm Laparoscopic Instruments - 00842102100321 Catalog Number : 92301

Device Description : St 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

Mediflex 3.5mm Laparoscopic Instruments - 00842102100338 Catalog Number : 92310

Device Description : Cvd Maryland Dissector, w/ Flush Port & non-Lock Handle, 3.5mmx26cm

Device Class : 2

Duns Number: 047644935

Premarket Exempt : No

Product Code : GCJ

Prescription Use : No

Device Count : 1

Mediflex 3.5mm Laparoscopic Instruments - 00842102100345 Catalog Number : 92311

Device Description : Straight Dissector, w/ Flush Port & non-Lock Handle, 3.5mmx26cm

Device Class : 2

Duns Number: 047644935

Premarket Exempt : No

Product Code : GCJ

Prescription Use : No

Device Count : 1

Mediflex 3.5mm Laparoscopic Instruments - 00842102100352 Catalog Number : 92320

Device Description : Crocodile Grasper, w/ Flush Port & Locking Handle, 3.5mmx26cm

Device Class : 2

Duns Number: 047644935

Premarket Exempt : No

Product Code : GCJ

Prescription Use : No

Device Count : 1

Mediflex 3.5mm Laparoscopic Instruments - 00842102100369 Catalog Number : 92321

Device Description : Standard Grasper, w/ Flush Port & Locking Handle, 3.5mmx26cm

Device Class : 2

Duns Number: 047644935

Premarket Exempt : No

Product Code : GCJ

Prescription Use : No

Device Count : 1

Mediflex 3.5mm Laparoscopic Instruments - 00842102100376 Catalog Number : 92322

Device Description : MediClinch Grasper, w/ Flush Port & Locking Handle, 3.5mmx26cm

Device Class : 2

Duns Number: 047644935

Premarket Exempt : No

Product Code : GCJ

Prescription Use : No

Device Count : 1

Mediflex 3.5mm Laparoscopic Instruments - 00842102100383 Catalog Number : 92323

Device Description : Wave Grasper, w/ Flush Port & Locking Handle, 3.5mmx26cm

Device Class : 2

Duns Number: 047644935

Premarket Exempt : No

Product Code : GCJ

Prescription Use : No

Device Count : 1

Mediflex 3.5mm Laparoscopic Instruments - 00842102100390 Catalog Number : 92324

Device Description : Retention Grasper, w/ Flush Port & Locking Handle, 3.5mmx26cm

Device Class : 2

Duns Number: 047644935

Premarket Exempt : No

Product Code : GCJ

Prescription Use : No

Device Count : 1

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