Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1119193

FEI Number

1119193

Entity Name

HOLLISTER INCORPORATED

City/State/Country

STUARTS DRAFT, VA, US

Establishment Address

366 Draft Ave, STUARTS DRAFT, VA 24477, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hollister Inc. (Owner Number: 1480288)

Owner / Operator Contact Address

2000 HOLLISTER DR., --, Libertyville, IL 60048, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 Hollister Female Urinary Pouch Male Urinary Pouch

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EZR	Cement, Stomal Appliance, Ostomy	Gastroenterology, Urology	Class 1	876.5900	1992-07-21
GDS	Bag, Stomal	Gastroenterology, Urology	Class 1	876.5900	1992-07-21
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2007-11-30
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	1996-06-14
EXD	Irrigator, Ostomy	Gastroenterology, Urology	Class 2	876.5895	1992-07-21
NOA	Device, Paste-On For Incontinence, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2006-09-27

Official Correspondent

Sofia Abreu Read

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Hollister Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3016675012	Hollister Lietuva UAB	Kaunas district, LT
9616668	HOLLISTER ULC	REHINS BALLINA Mayo, IE
2320961	HOLLISTER, INC.	Mount Juliet, TN, US
3014404707	Hollister Services BV	Roosendaal Noord-Brabant, NL
1480288	HOLLISTER INCORPORATED	LIBERTYVILLE, IL, US

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1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1119193. Last updated year: 2026. Please use registration number 1119193 when referencing this establishment in official correspondence.