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 Hemodialysis Fistula Needle Set with MasterGuard - 00842289100305 Catalog Number :

Device Description : MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 16G X 1" WITH MASTERGUARD INCLUDED WITH T MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 16G X 1" WITH MASTERGUARD INCLUDED WITH TWINPACK D9-2006MG

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 - 00842289100312 Catalog Number :

Device Description : MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 16G X 1" WITH MASTERGUARD INCLUDED WITH MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 16G X 1" WITH MASTERGUARD INCLUDED WITH TWINPACK D9-2006MG

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 - 00842289100329 Catalog Number :

Device Description : MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 16G X 1" WITH MASTERGUARDTotal Case Qty MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 16G X 1" WITH MASTERGUARDTotal Case Qty 250 (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 - 00842289100336 Catalog Number :

Device Description : MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 16G X 1" LONG BEVEL WITH MASTERGUARD INCL MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 16G X 1" LONG BEVEL WITH MASTERGUARD INCLUDED WITH TWINPACK D9-2006MGLB

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 - 00842289100343 Catalog Number :

Device Description : MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 16G X 1" LONG BEVEL WITH MASTERGUARD INC MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 16G X 1" LONG BEVEL WITH MASTERGUARD INCLUDED WITH TWINPACK D9-2006MGLB

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 - 00842289100350 Catalog Number :

Device Description : MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 16G X 1" LONG BEVEL WITH MASTERGUARDTota MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 16G 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 - 00842289100367 Catalog Number :

Device Description : MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 17G X 1" WITH MASTERGUARD INCLUDED WITH T MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 17G X 1" WITH MASTERGUARD INCLUDED WITH TWINPACK D9-2007MG

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 - 00842289100374 Catalog Number :

Device Description : MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 17G X 1" WITH MASTERGUARD INCLUDED WITH MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 17G X 1" WITH MASTERGUARD INCLUDED WITH TWINPACK D9-2007MG

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 - 00842289100381 Catalog Number :

Device Description : MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 17G X 1" WITH MASTERGUARDTotal Case Qty MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 17G X 1" 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 - 00842289100398 Catalog Number :

Device Description : MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 17G X 1" LONG BEVEL WITH MASTERGUARD INCL MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 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

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