FDA Registration
Active
🇲🇽 Mexico
OPOS21L, 21G Laminar Flow Irrigation Sleeve, Reusable
Reg #: 3010291427
·
FEI: 3010291427
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- AvailMed S.A.De C.V.
- Registration Number
- 3010291427
- FEI Number
- 3010291427
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- C.Industrial Lt.001 Mz.105, No. 20905 Int.A. Col. Cd. Industrial
- City
- Tijuana Baja California
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K844373
Owner / Operator
- Firm Name
- Flextronics International USA, Inc.
- Operator Number
- 9006592
- Address
- 6201 America Center Drive
- City
- San Jose
- State
- CA
- Postal Code
- 95002
- Country
- US
- Correspondent
- Chad Ashton
US Agent
- Business Name
- FLEXTRONICS INTERNATIONAL USA, INC.
- Contact Name
- Chad Ashton
- Address
- 12455 Research Blvd
- City
- Austin
- State
- TX
- ZIP
- 78759
- Country
- US
- [email protected]
- Phone
- 901 8712423
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Unit, Phacofragmentation | HQC | Class 2 | Ophthalmic | No | 2017-05-04 |
Proprietary Names
OPOS21L, 21G Laminar Flow Irrigation Sleeve, Reusable
OPOS21LD, 21G Laminar Flow Irrigation Sleeve
OM5240011, Aspirant Collection Bag
OPOS20LD, 20G Laminar Flow Irrigation Sleeve
OM3452032, OMS Infusion Sleeve, Reusable
OPOS20L, 20G Laminar Flow Irrigation Sleeve, Reusable
OPOS19L, 19G Laminar Flow Irrigation Sleeve, Reusable
OM3452022, Phacotest Chamber, Reusable
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)