FDA Registration
Active
🇺🇸 United States
Natrelle Re-ster Sizers: MSZ-10, MSZ-15, MSZ-20, MSZ-45
Reg #: 2011068
·
FEI: 2011068
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ALLERGAN SALES, LLC
- Registration Number
- 2011068
- FEI Number
- 2011068
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2525 DUPONT DR
- City
- IRVINE
- State
- CA
- ZIP
- 92612
- Country
- US
Regulatory Submissions
- 510(k) Number
- K831566
Owner / Operator
- Firm Name
- AbbVie, Inc.
- Operator Number
- 2011068
- Address
- 2525 DUPONT DRIVE, --
- City
- Irvine
- State
- CA
- Postal Code
- 92612
- Country
- US
- Correspondent
- James P Wabby
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mammary Sizer | MRD | Class U | Unknown | No | 2014-12-19 |
Proprietary Names
Natrelle Re-ster Sizers: MSZ-10, MSZ-15, MSZ-20, MSZ-45
Natrelle410 Re-ster Sizers:MSZ-FL, MSZ-ML,MSZ-LL, MSZ-LM, MSZ-MX, MSZ-LF, MSZ-FX, MSZ-LX, MSZ-MM, MSZ-MF, MSZ-FM, MSZ-FF
Natrelle Inspira Re-ster Sizers: MSZ-F, MSZ-L, MSZ-LP, MSZ-M, MSZ-X, , MSZST-F, MSZST-L, MSZST-LP, MSZST-M, MSZST-X
Natrelle Re-sterilizable Sizer: MSZ
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility