HOLLISTER INCORPORATED

HOLLISTER INCORPORATED

Address:1502 E Laharpe St,KIRKSVILLE,MO,63501,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

CATHETER, URETHRAL (GBM) (7) COLLECTOR, OSTOMY (EXB) (2) TUBES, GASTROINTESTINAL (AND ACCESSORIES) (KNT) (1)

Premarket Exempt

No Yes

Clear

Pouchkins - 00610075037773 Catalog Number :

Device Description : Premie One-Piece Ostomy Pouch – Flat Cut-to-Fit Barrier_15mm 5/8"

Device Class :

Duns Number: 005527098

Premarket Exempt : Yes

Product Code : EXB

Prescription Use : No

Device Count : 15

Pouchkins - 00610075037780 Catalog Number :

Device Description : Newborn One-Piece Ostomy Pouch – Flat Cut-to-Fit Barrier_35x22mm 1-3/8x7/8"

Device Class :

Duns Number: 005527098

Premarket Exempt : Yes

Product Code : EXB

Prescription Use : No

Device Count : 15

InstaFlo - 00610075040070 Catalog Number :

Device Description : Bowel Catheter System

Device Class : 2

Duns Number: 005527098

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

Apogee HC - 00610075052332 Catalog Number :

Device Description : Hydrophilic Intermittent Catheter, 8 Fr 10 in, Straight

Device Class :

Duns Number: 005527098

Premarket Exempt : No

Product Code : GBM

Prescription Use : Yes

Device Count : 30

Apogee HC - 00610075052349 Catalog Number :

Device Description : Hydrophilic Intermittent Catheter, 10 Fr 6 in, Straight

Device Class :

Duns Number: 005527098

Premarket Exempt : No

Product Code : GBM

Prescription Use : Yes

Device Count : 30

Apogee HC - 00610075052356 Catalog Number :

Device Description : Hydrophilic Intermittent Catheter, 10 Fr 10 in, Straight

Device Class :

Duns Number: 005527098

Premarket Exempt : No

Product Code : GBM

Prescription Use : Yes

Device Count : 30

Apogee HC - 00610075052363 Catalog Number :

Device Description : Hydrophilic Intermittent Catheter, 12 Fr 6 in, Straight

Device Class :

Duns Number: 005527098

Premarket Exempt : No

Product Code : GBM

Prescription Use : Yes

Device Count : 30

Apogee HC - 00610075052370 Catalog Number :

Device Description : Hydrophilic Intermittent Catheter, 12 Fr 16 in, Straight

Device Class :

Duns Number: 005527098

Premarket Exempt : No

Product Code : GBM

Prescription Use : Yes

Device Count : 30

Apogee HC - 00610075052387 Catalog Number :

Device Description : Hydrophilic Intermittent Catheter, 14 Fr 6 in, Straight

Device Class :

Duns Number: 005527098

Premarket Exempt : No

Product Code : GBM

Prescription Use : Yes

Device Count : 30

Apogee HC - 00610075052394 Catalog Number :

Device Description : Hydrophilic Intermittent Catheter, 14 Fr 16 in, Straight

Device Class :

Duns Number: 005527098

Premarket Exempt : No

Product Code : GBM

Prescription Use : Yes

Device Count : 30

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