FDA Registration
Active
🇺🇸 United States
BiomericsCatheterResearch6631 (LN) - 61-5207 Heartland Medical H-S Procedure Tray
Reg #: 1450662
·
FEI: 1450662
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Isomedix Operations, Inc.
- Registration Number
- 1450662
- FEI Number
- 1450662
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1880 Industrial Dr
- City
- Libertyville
- State
- IL
- ZIP
- 60048
- 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 |
|---|---|---|---|---|---|
| Tray, Surgical, Ent | MMO | Class 1 | Ear, Nose, Throat | No | 2012-12-27 |
Proprietary Names
BiomericsCatheterResearch6631 (LN) - 61-5207 Heartland Medical H-S Procedure Tray
BiomericsCatheterResearch6631 (LN) - Tray-HS-7FR Bulk Sterile, HSG Tray with 7fr HS
BiomericsCatheterResearch6631 (LN) - 61-5205 Heartland Medical H-S Procedure Tray
BiomericsCatheterResearch6631 (LN) - Tray-sub bulk sterile, hsg tray, 10-case
BiomericsCatheterResearch6631 (LN) - Tray shapable-7fr bulk sterile,hsg tray with shapeable
BiomericsCatheterResearch6631 (LN) - Tray-HS-5FR Bulk Sterile, HSG Tray with 5fr HS
BiomericsCatheterResearch6631 (LN) - Tray-shapable-5fr bulk sterils,hsg tray with shapeab
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)