FDA Registration Active 🇺🇸 United States

HOLLISTER INCORPORATED

Reg #: 1119193 · FEI: 1119193 · Expires 2026
Products
12
Proprietary Names
54
Establishment Types
2
Classifications
12

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Registration Details

Registration Name
HOLLISTER INCORPORATED
Registration Number
1119193
FEI Number
1119193
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
366 Draft Ave
City
STUARTS DRAFT
State
VA
ZIP
24477
Country
US

Regulatory Submissions

510(k) Number
K862573

Owner / Operator

Firm Name
Hollister Inc.
Operator Number
1480288
Address
2000 HOLLISTER DR., --
City
Libertyville
State
IL
Postal Code
60048
Country
US
Correspondent
Sofia Abreu Read

Products

Device Name Product Code
Cement, Stomal Appliance, Ostomy EZR
Bag, Stomal GDS
Catheter, Irrigation GBX
Device, Fixation, Tracheal Tube CBH
Irrigator, Ostomy EXD
Device, Paste-On For Incontinence, Non-Sterile NOA
Ostomy Care Kit PQE
Tubes, Gastrointestinal (And Accessories) KNT
Dressing, Wound, Occlusive NAD
Collector, Ostomy EXB
Bag, Urine Collecting, Ureterostomy EXG
Protector, Ostomy EXE

Proprietary Names

ADAPT PREMIUM Securi-T USA KARAYA HOLLISTER HOLLISTER STOMA BAGS HOLLISTER DRAINING WOUND MANAGEMENT STOMA BAGS Hollister AnchorFast AnchorFast Guard Select AnchorFast SlimFit AnchorFast Guard New Image Female Urinary Pouch Male Urinary Pouch Nova Conform 2 Premier ModermaFlex Restore Vertical Drain/Tube Attachment Device Karaya 5 Compact Tandem Suavita Pouchkins Hollister Solo Holligard Fecal Collectors NovaLife NovaLife 2 Adapt Center Point Lock First Choice DuoSoft Moderma Flex NovaLife 2 GX+ m9 Nova 2 Invent Dansac Novalife 1 NovaLife 1 NovaLife 1 GX+ Impression - C HOLLISTER UROSTOMY BAGS Urostomy Bags TRE CeraPlus Premium Nova 1 HolliHesive Karaya

Establishment Types

Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)