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 - 00842289100404 Catalog Number :

Device Description : MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 17G X 1" LONG BEVEL WITH MASTERGUARD INC MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 17G X 1" LONG BEVEL WITH MASTERGUARD INCLUDED WITH TWINPACK D9-2007MGLB

Device Class : 2

Duns Number: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuard - 00842289100411 Catalog Number :

Device Description : MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 17G X 1" LONG BEVEL WITH MASTERGUARDTota MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 17G X 1" LONG BEVEL 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 Hemodialysis Fistula Needle Set with MasterGuard - 00842289100428 Catalog Number :

Device Description : MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 15G X 1 1/4" WITH MASTERGUARD INCLUDED WI MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 15G X 1 1/4" WITH MASTERGUARD INCLUDED WITH TWINPACK D9-2015MG

Device Class : 2

Duns Number: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuard - 00842289100435 Catalog Number :

Device Description : MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 15G X 1 1/4" WITH MASTERGUARD INCLUDED W MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 15G X 1 1/4" WITH MASTERGUARD INCLUDED WITH TWINPACK D9-2015MG

Device Class : 2

Duns Number: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuard - 00842289100442 Catalog Number :

Device Description : MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 15G X 1 1/4" WITH MASTERGUARDTotal Case MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 15G X 1 1/4" 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 Hemodialysis Fistula Needle Set with MasterGuard - 00842289100459 Catalog Number :

Device Description : MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 16G X 1 1/4" WITH MASTERGUARD INCLUDED WI MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 16G X 1 1/4" WITH MASTERGUARD INCLUDED WITH TWINPACK D9-2016MG

Device Class : 2

Duns Number: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuard - 00842289100466 Catalog Number :

Device Description : MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 16G X 1 1/4" WITH MASTERGUARD INCLUDED W MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 16G X 1 1/4" WITH MASTERGUARD INCLUDED WITH TWINPACK D9-2016MG

Device Class : 2

Duns Number: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuard - 00842289100473 Catalog Number :

Device Description : MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 16G X 1 1/4" WITH MASTERGUARDTotal Case MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 16G X 1 1/4" 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 Hemodialysis Fistula Needle Set with MasterGuard - 00842289100480 Catalog Number :

Device Description : MEDISYSTEMS SINGLE PACK FISTULA NEEDLE SET 15G X 1" ROTATABLE HUB WITH MASTERGUA MEDISYSTEMS SINGLE PACK FISTULA NEEDLE SET 15G X 1" ROTATABLE HUB WITH MASTERGUARD INCLUDED WITH TWINPACK D9-6005MG

Device Class : 2

Duns Number: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

Medisystems TwinPack Hemodialysis Fistula Needle Set with MasterGuard - 00842289100497 Catalog Number :

Device Description : MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 15G X 1" ROTATABLE HUB WITH MASTERGUARD MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 15G X 1" ROTATABLE HUB WITH MASTERGUARD INCLUDED WITH TWINPACK D9-6005MG

Device Class : 2

Duns Number: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

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