FDA Registration
Active
🇺🇸 United States
Cryolife1999 (SP) - BGST-12 12mm Spreader Tip
Reg #: 1450662
·
FEI: 1450662
·
Expires 2025
Products
1
Proprietary Names
11
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
Regulatory Submissions
- PMA Number
- P010003
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 |
|---|---|---|---|---|---|
| Glue, Surgical, Arteries | MUQ | Class 3 | Unknown | No | 2014-04-01 |
Proprietary Names
Cryolife1999 (SP) - BGST-12 12mm Spreader Tip
Cryolife1999 (SP) - BGST-16 16mm Spreader Tip
Cryolife1999 (SP) - BGAT-SY Mixing Tip
Cryolife1999 (SP) - BG3502 BioGlue 2 mL
Artivion10572 (SP) - BG3510 BioGlue 10 mL
Artivion10572 (SP) - BG3502 BioGlue 2 mL
Cryolife1999 (SP) - BioGlue Surgical Adhesive
Artivion10572 (SP) - BG3515 BioGlue 5 mL
Artivion10572 (LN,SP) - BG3510 BioGlue Surgical Adhesive, 10mL
Artivion10572 (LN,SP) - BG3515 BioGlue Surgical Adhesive, 5mL
Artivion10572 (LN,SP) - BG3502 BioGlue Surgical Adhesive, 2mL
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)