FDA Registration
Active
🇺🇸 United States
83050010, 83050060, 83060010, 83060060
Reg #: 1216677
·
FEI: 1216677
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- COOPERSURGICAL, INC.
- Registration Number
- 1216677
- FEI Number
- 1216677
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 95 CORPORATE DRIVE
- City
- Trumbull
- State
- CT
- ZIP
- 06611
- Country
- US
Regulatory Submissions
- 510(k) Number
- K133387
Owner / Operator
- Firm Name
- COOPERSURGICAL, INC.
- Operator Number
- 9002384
- Address
- 95 CORPORATE DR., --
- City
- Trumbull
- State
- CT
- Postal Code
- 06611
- Country
- US
- Correspondent
- Mauro Castro
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Media, Reproductive | MQL | Class 2 | Obstetrics/Gynecology | No | 2021-03-12 |
Proprietary Names
83050010, 83050060, 83060010, 83060060
83050010D, 83050060D, 83060010D, 83060060D
83050010F, 83050060F, 83060010F, 83060060F
ORIGIO Sequential Blast
83050010A, 83050060A, 83060010A, 83060060A
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility