MEDISYSTEMS 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

Needle, Fistula (FIE) (10)

Premarket Exempt

Clear

Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuard - 00842289100503 Catalog Number :

Device Description : MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 15G X 1" ROTATABLE HUB WITH MASTERGUARDT MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 15G X 1" ROTATABLE HUB WITH MASTERGUARDTotal Case Qty 250 (Includes 120 Twin Pouches + 10 Single Pouches)

Device Class : 2

Duns Number: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

Medisystems Button Hole Needle Set with SteriPick - 00842289100510 Catalog Number :

Device Class : 2

Duns Number: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

Medisystems Button Hole Needle Set with SteriPick - 00842289100527 Catalog Number :

Device Class : 2

Duns Number: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

Medisystems Button Hole Needle Set with SteriPick - 00842289100534 Catalog Number :

Device Class : 2

Duns Number: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

Medisystems Button Hole Needle Set - 00842289100541 Catalog Number :

Device Class : 2

Duns Number: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

Medisystems Button Hole Needle Set - 00842289100558 Catalog Number :

Device Class : 2

Duns Number: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

Medisystems Button Hole Needle Set with SteriPick - 00842289100565 Catalog Number :

Device Class : 2

Duns Number: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

Medisystems Button Hole Needle Set with SteriPick - 00842289100572 Catalog Number :

Device Class : 2

Duns Number: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

Medisystems Button Hole Needle Set - 00842289100589 Catalog Number :

Device Class : 2

Duns Number: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

Medisystems Button Hole Needle Set - 00842289100596 Catalog Number :

Device Class : 2

Duns Number: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

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