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 ButtonHole Needle Set with SteriPick - 00842289100206 Catalog Number :

Device Description : MEDISYSTEMS TWINPACK BUTTONHOLE FISTULA NEEDLE SET 17G X 3/5" W/ STERIPICK TOTAL MEDISYSTEMS TWINPACK BUTTONHOLE FISTULA NEEDLE SET 17G X 3/5" W/ STERIPICK TOTAL CASE QTY 250 (115 TWIN POUCHES + 20 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 - 00842289100213 Catalog Number :

Device Description : MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 14G X 1" WITH MASTERGUARD INCLUDED WITH T MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 14G X 1" WITH MASTERGUARD INCLUDED WITH TWINPACK D9-2004MG

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 - 00842289100220 Catalog Number :

Device Description : MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 14G X 1" WITH MASTERGUARD INCLUDED WITH MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 14G X 1" WITH MASTERGUARD INCLUDED WITH TWINPACK D9-2004MG

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 - 00842289100237 Catalog Number :

Device Description : MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 14G X 1" WITH MASTERGUARDTotal Case Qty MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 14G 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 - 00842289100244 Catalog Number :

Device Description : MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 15G X 1" WITH MASTERGUARD INCLUDED WITH T MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 15G X 1" WITH MASTERGUARD INCLUDED WITH TWINPACK D9-2005MG

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 - 00842289100251 Catalog Number :

Device Description : MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 15G X 1" WITH MASTERGUARD INCLUDED WITH MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 15G X 1" WITH MASTERGUARD INCLUDED WITH TWINPACK D9-2005MG

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 - 00842289100268 Catalog Number :

Device Description : MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 15G X 1" WITH MASTERGUARDTotal Case Qty MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 15G 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 - 00842289100275 Catalog Number :

Device Description : MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 15G X 1" LONG BEVEL WITH MASTERGUARD INCL MEDISYSTEMS SINGLE PACK FISTULA NEEDLE 15G X 1" LONG BEVEL WITH MASTERGUARD INCLUDED WITH TWINPACK D9-2005MGLB

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 - 00842289100282 Catalog Number :

Device Description : MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 15G X 1" LONG BEVEL WITH MASTERGUARD INC MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 15G X 1" LONG BEVEL WITH MASTERGUARD INCLUDED WITH TWINPACK D9-2005MGLB

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 - 00842289100299 Catalog Number :

Device Description : MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 15G X 1" LONG BEVEL WITH MASTERGUARDTota MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 15G X 1" LONG BEVEL 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

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