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 TWINPACK+ NEEDLE SET - 00842289102033 Catalog Number :

Device Description : TWINPACK BUTTONHOLE FISTULA NEEDLE SET 15G X 3/5" W/ STERIPICK INCLUDED WITH TWI TWINPACK BUTTONHOLE FISTULA NEEDLE SET 15G X 3/5" W/ STERIPICK INCLUDED 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 TWINPACK+ NEEDLE SET - 00842289102040 Catalog Number :

Device Description : TWINPACK BUTTONHOLE FISTULA NEEDLE SET 15G X 3/5" W/ STERIPICK TOTAL CASE QTY 25 TWINPACK BUTTONHOLE FISTULA NEEDLE SET 15G X 3/5" W/ STERIPICK TOTAL CASE QTY 250 (115 TWIN POUCHES + 20 SINGLE POUCHES)

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

ButtonHole with SteriPick TWINPACK+ NEEDLE SET - 00842289102057 Catalog Number :

Device Description : TWINPACK BUTTONHOLE FISTULA NEEDLE SET 16G X 3/5" W/ STERIPICK INCLUDED WITH TWI TWINPACK BUTTONHOLE FISTULA NEEDLE SET 16G X 3/5" W/ STERIPICK INCLUDED 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 TWINPACK+ NEEDLE SET - 00842289102064 Catalog Number :

Device Description : TWINPACK BUTTONHOLE FISTULA NEEDLE SET 16G X 3/5" W/ STERIPICK TOTAL CASE QTY 25 TWINPACK BUTTONHOLE FISTULA NEEDLE SET 16G X 3/5" W/ STERIPICK TOTAL CASE QTY 250 (115 TWIN POUCHES + 20 SINGLE POUCHES)

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

ButtonHole with SteriPick TWINPACK+ NEEDLE SET - 00842289102071 Catalog Number :

Device Description : TWINPACK BUTTONHOLE FISTULA NEEDLE SET 17G X 3/5" W/ STERIPICK INCLUDED WITH TWI TWINPACK BUTTONHOLE FISTULA NEEDLE SET 17G X 3/5" W/ STERIPICK INCLUDED WITH TWINPACK BH-2037PE

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

ButtonHole with SteriPick TWINPACK+ NEEDLE SET - 00842289102088 Catalog Number :

Device Description : TWINPACK BUTTONHOLE FISTULA NEEDLE SET 17G X 3/5" W/ STERIPICK TOTAL CASE QTY 25 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: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS - 00842289102095 Catalog Number :

Device Description : TWINPACK FISTULA NEEDLE SET 14G X 1" WITH MASTERGUARD PLUSTotal Case Qty 250 (12 TWINPACK FISTULA NEEDLE SET 14G X 1" WITH MASTERGUARD PLUSTotal Case Qty 250 (120 Twin pouches + 10 Single pouches)

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS - 00842289102101 Catalog Number :

Device Description : TWINPACK FISTULA NEEDLE SET 14G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPAC TWINPACK FISTULA NEEDLE SET 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 TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS - 00842289102118 Catalog Number :

Device Description : TWINPACK FISTULA NEEDLE SET 15G X 1" WITH MASTERGUARD PLUS INCLUDED WITH TWINPAC TWINPACK FISTULA NEEDLE SET 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 TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS - 00842289102125 Catalog Number :

Device Description : TWINPACK FISTULA NEEDLE SET 15G X 1" WITH MASTERGUARD PLUSTotal Case Qty 250 (12 TWINPACK FISTULA NEEDLE SET 15G X 1" WITH MASTERGUARD PLUSTotal Case Qty 250 (120 Twin pouches + 10 Single pouches)

Device Class : 2

Duns Number: 088013219

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

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