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 Button Hole Needle Set with SteriPick - 00842289100107 Catalog Number :

Device Description : MEDISYSTEMS SINGLE PACK BUTTONHOLE FISTULA NEEDLE SET 17G X 1" WITH STERIPICK IN MEDISYSTEMS SINGLE PACK BUTTONHOLE FISTULA NEEDLE SET 17G X 1" WITH STERIPICK INCLUDED WITH TWINPACK BH-2007PE

Device Class : 2

Duns Number: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

Medisystems TwinPack ButtonHole Needle Set with SteriPick - 00842289100114 Catalog Number :

Device Description : MEDISYSTEMS TWINPACK BUTTONHOLE FISTULA NEEDLE SET 17G X 1" W/ STERIPICK TOTAL C MEDISYSTEMS TWINPACK BUTTONHOLE FISTULA NEEDLE SET 17G X 1" 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 TwinPack ButtonHole Needle Set with SteriPick - 00842289100121 Catalog Number :

Device Description : MEDISYSTEMS TWINPACK BUTTONHOLE FISTULA NEEDLE SET 15G X 3/5" W/ STERIPICK INCLU MEDISYSTEMS TWINPACK BUTTONHOLE FISTULA NEEDLE SET 15G X 3/5" W/ STERIPICK INCLUDED WITH TWINPACK BH-2035PE

Device Class : 2

Duns Number: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

Medisystems Button Hole Needle Set with SteriPick - 00842289100138 Catalog Number :

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

Device Class : 2

Duns Number: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

Medisystems TwinPack ButtonHole Needle Set with SteriPick - 00842289100145 Catalog Number :

Device Description : MEDISYSTEMS TWINPACK BUTTONHOLE FISTULA NEEDLE SET 15G X 3/5" W/ STERIPICK TOTAL MEDISYSTEMS 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: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

Medisystems Button Hole Needle Set with SteriPick - 00842289100152 Catalog Number :

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

Device Class : 2

Duns Number: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

Medisystems TwinPack ButtonHole Needle Set with SteriPick - 00842289100169 Catalog Number :

Device Description : MEDISYSTEMS TWINPACK BUTTONHOLE FISTULA NEEDLE SET 16G X 3/5" W/ STERIPICK INCLU MEDISYSTEMS TWINPACK BUTTONHOLE FISTULA NEEDLE SET 16G X 3/5" W/ STERIPICK INCLUDED WITH TWINPACK BH-2036PE

Device Class : 2

Duns Number: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

Medisystems TwinPack ButtonHole Needle Set with SteriPick - 00842289100176 Catalog Number :

Device Description : MEDISYSTEMS TWINPACK BUTTONHOLE FISTULA NEEDLE SET 16G X 3/5" W/ STERIPICK TOTAL MEDISYSTEMS 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: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

Medisystems Button Hole Needle Set with SteriPick - 00842289100183 Catalog Number :

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

Device Class : 2

Duns Number: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

Medisystems TwinPack ButtonHole Needle Set with SteriPick - 00842289100190 Catalog Number :

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

Device Class : 2

Duns Number: 061310132

Premarket Exempt : No

Product Code : FIE

Prescription Use : Yes

Device Count : 1

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