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 - 00842289101104 Catalog Number :

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 - 00842289101111 Catalog Number :

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 - 00842289101128 Catalog Number :

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 - 00842289101135 Catalog Number :

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 - 00842289101142 Catalog Number :

Device Class : 2

Duns Number: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

Medisystems Button Hole Single Needle Set - 00842289101159 Catalog Number :

Device Class :

Duns Number: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

Medisystems Button Hole Single Needle Set - 00842289101166 Catalog Number :

Device Class :

Duns Number: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

Medisystems Single Needle Set - 00842289101173 Catalog Number :

Device Class : 2

Duns Number: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

Medisystems Single Needle Set - 00842289101180 Catalog Number :

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 - 00842289101197 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 D9-2005MGP

Device Class : 2

Duns Number: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

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