FDA Registration
Active
🇺🇸 United States
77010003D
Reg #: 1216677
·
FEI: 1216677
·
Expires 2025
Products
1
Proprietary Names
9
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
- K172197
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
77010003D
77020003F
77010003F
SAGE 1-Step GM-CSF
77010003
77020003A
77020003
77010003A
77020003D
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198