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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cement, Stomal Appliance, Ostomy | EZR | Class 1 | Gastroenterology, Urology | No | 1992-07-21 |
| Bag, Stomal | GDS | Class 1 | Gastroenterology, Urology | No | 1992-07-21 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2007-11-30 |
| Device, Fixation, Tracheal Tube | CBH | Class 1 | Anesthesiology | No | 1996-06-14 |
| Irrigator, Ostomy | EXD | Class 2 | Gastroenterology, Urology | No | 1992-07-21 |
| Device, Paste-On For Incontinence, Non-Sterile | NOA | Class 1 | Gastroenterology, Urology | No | 2006-09-27 |
| Ostomy Care Kit | PQE | Class 1 | Gastroenterology, Urology | No | 2022-07-14 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2006-05-24 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2001-08-01 |
| Collector, Ostomy | EXB | Class 1 | Gastroenterology, Urology | No | 2006-09-27 |
| Bag, Urine Collecting, Ureterostomy | EXG | Class 1 | Gastroenterology, Urology | No | 1992-07-21 |
| Protector, Ostomy | EXE | Class 1 | Gastroenterology, Urology | No | 2006-09-27 |
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)