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 (FFO) (4) Table And Attachments, Operating-Room (BWN) (3) Clip, Implantable (FZP) (1)

Premarket Exempt

No Yes

Clear

Mediflex Universal Round Bar Table Mounted Retractor Systems - 00842102115011 Catalog Number :

Device Description : URB Balfour blade, SM Lip, 2 3/4 "x 3"

Device Class : 1

Duns Number: 047644935

Premarket Exempt : Yes

Product Code : FFO

Prescription Use : No

Device Count : 1

Mediflex Universal Round Bar Table Mounted Retractor Systems - 00842102115028 Catalog Number :

Device Description : URB Balfour blade, SM lip, 3 1/4" x 3"

Device Class : 1

Duns Number: 047644935

Premarket Exempt : Yes

Product Code : FFO

Prescription Use : No

Device Count : 1

StrongArm Surgical Holders and Positioners - 00842102115035 Catalog Number :

Device Description : StrongArm, Top Mount, 16.5" Long post w/ QC Fitting

Device Class : 1

Duns Number: 047644935

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : No

Device Count : 1

Flexarm Surgical Holders and Positioners - 00842102115042 Catalog Number :

Device Description : Ureteral Access Sheath Stabilization System - includes: UAS Arm, Mount Post, Rail Clamp

Device Class : 1

Duns Number: 047644935

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : No

Device Count : 1

Flexarm Surgical Holders and Positioners - 00842102115059 Catalog Number :

Device Description : CystoAssist System - FlexArm Mini, Cysto Sheath Holding Tip (Storz compat), Mou CystoAssist System - FlexArm Mini, Cysto Sheath Holding Tip (Storz compat), Mount Post, Rail Clamp

Device Class : 1

Duns Number: 047644935

Premarket Exempt : Yes

Product Code : BWN

Prescription Use : No

Device Count : 1

Mediflex Universal Round Bar Table Mounted Retractor Systems - 00842102115066 Catalog Number :

Device Description : Balfour Mayo Swivel Blade, 3 1/2" x 2 3/4"

Device Class : 1

Duns Number: 047644935

Premarket Exempt : Yes

Product Code : FFO

Prescription Use : No

Device Count : 1

Bookler Table Mounted Retractor Systems - 00842102115073 Catalog Number :

Device Description : Stainless Steel Post Couplers 1/2" x 1"

Device Class : 1

Duns Number: 047644935

Premarket Exempt : Yes

Product Code : FFO

Prescription Use : No

Device Count : 1

Mediflex Medi-Clip - 10842102105019 Catalog Number : 50120-ML

Device Description : Medium Large Clips - 1 Cartridge/1 Pouch

Device Class : 2

Duns Number: 047644935

Premarket Exempt : No

Product Code : FZP

Prescription Use : No

Device Count : 1

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