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 - 00842289101203 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 D9-2005MGP

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 - 00842289101210 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 TwinPack Hemodialysis Fistula Needle Set with MasterGuard - 00842289101227 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 D9-2006MGP

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 - 00842289101234 Catalog Number :

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

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 - 00842289101241 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 Plus - 00842289101272 Catalog Number :

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

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 Plus - 00842289101289 Catalog Number :

Device Description : MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 14G X 1" WITH MASTERGUARD PLUSTotal Case MEDISYSTEMS TWINPACK FISTULA NEEDLE SET 14G X 1" WITH MASTERGUARD PLUSTotal 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 TwinPack Hemodialysis Fistula Needle Set with Masterguard Plus - 00842289101296 Catalog Number :

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

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 Plus - 00842289101302 Catalog Number :

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

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 Plus - 00842289101319 Catalog Number :

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

Device Class : 2

Duns Number: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

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