FDA Registration
Active
🇺🇸 United States
Hollister (SP,LS,LN) -First Choice; Holligard; Hollister Solo Stoma Cap; Invent; Karaya 5; Moderma Flex; New Image
Reg #: 3009888344
·
FEI: 3009888344
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Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Isomedix Operations Inc
- Registration Number
- 3009888344
- FEI Number
- 3009888344
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1441 Don Haskins Dr
- City
- El Paso
- State
- TX
- ZIP
- 79936
- Country
- US
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 1527821
- Address
- 5960 Heisley Rd, --
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Collector, Ostomy | EXB | Class 1 | Gastroenterology, Urology | No | 2012-10-26 |
Proprietary Names
Hollister (SP,LS,LN) -First Choice; Holligard; Hollister Solo Stoma Cap; Invent; Karaya 5; Moderma Flex; New Image
Hollister (SP,LS,LN) - Adapt; Center Point Lock; Compact; Conform 2; Dansac; Drainable Pouch Clamp; DuoSoft; Fecal Colle
Hollister (SP,LS,LN) - Premier; Restore; Securi-T USA; Suavita; Tandem; Urostomy Drain Tube Adapter
Hollister (LN, LS) - Hollister
Hollister (LN, LS) - Ostomy Skin Barriers
Hollister (SP,LS,LN) - Moderma Flex; New Image; Nova 2; NovaLife 1; NovaLife 1 GX+; NovaLife 2; NovaLife 2 GX+; Pouchkin
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)