NXSTAGE MEDICAL, INC.

Address:350 Merrimack St,LAWRENCE,MA,01843,US

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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

ButtonHole with SteriPick NEEDLE SET - 00842289102330 Catalog Number :

Device Description : SINGLE PACK BUTTONHOLE FISTULA NEEDLE SET 15G X 3/5" W/ STERIPICKINCLUDED WITH T SINGLE PACK BUTTONHOLE FISTULA NEEDLE SET 15G X 3/5" W/ STERIPICKINCLUDED WITH TWINPACK BH-2035PE

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

ButtonHole with SteriPick NEEDLE SET - 00842289102347 Catalog Number :

Device Description : SINGLE PACK BUTTONHOLE FISTULA NEEDLE SET 16G X 3/5" W/ STERIPICKINCLUDED WITH T SINGLE PACK BUTTONHOLE FISTULA NEEDLE SET 16G X 3/5" W/ STERIPICKINCLUDED WITH TWINPACK BH-2036PE

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

ButtonHole with SteriPick NEEDLE SET - 00842289102354 Catalog Number :

Device Description : SINGLE PACK BUTTONHOLE FISTULA NEEDLE SET 17G X 3/5" W/ STERIPICKINCLUDED WITH T SINGLE PACK BUTTONHOLE FISTULA NEEDLE SET 17G X 3/5" W/ STERIPICKINCLUDED WITH TWINPACK BH-2037PE

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

masterguard plus HEMODIALYSIS FISTULA NEEDLE SET - 00842289102361 Catalog Number :

Device Description : SINGLE PACK FISTULA NEEDLE 15G X 1" ROTATABLE HUB WITH MASTERGUARD PLUS INCLUDED SINGLE PACK FISTULA NEEDLE 15G X 1" ROTATABLE HUB WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-6005MGP

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

masterguard plus HEMODIALYSIS FISTULA NEEDLE SET - 00842289102378 Catalog Number :

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

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

masterguard plus HEMODIALYSIS FISTULA NEEDLE SET - 00842289102385 Catalog Number :

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

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

masterguard plus HEMODIALYSIS FISTULA NEEDLE SET - 00842289102392 Catalog Number :

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

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

masterguard plus HEMODIALYSIS FISTULA NEEDLE SET - 00842289102408 Catalog Number :

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

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

masterguard plus HEMODIALYSIS FISTULA NEEDLE SET - 00842289102415 Catalog Number :

Device Description : SINGLE PACK FISTULA NEEDLE 16G X 1" LONG BEVEL WITH MASTERGUARD PLUS INCLUDED WI SINGLE PACK FISTULA NEEDLE 16G X 1" LONG BEVEL WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2006MGPLB

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

masterguard plus HEMODIALYSIS FISTULA NEEDLE SET - 00842289102422 Catalog Number :

Device Description : SINGLE PACK FISTULA NEEDLE 17G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK SINGLE PACK FISTULA NEEDLE 17G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPACK D9-2007MGP

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

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