FDA Registration
Active
🇯🇵 Japan
Two-Toned Bonded Gemini Sterilization Wrap
Reg #: 3016073670
·
FEI: 3016073670
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Medline Logistics Japan G.K.
- Registration Number
- 3016073670
- FEI Number
- 3016073670
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 34-1 Toriisaki
- City
- Nishihocho, Aisai-shi Aichi
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K152458
Owner / Operator
- Firm Name
- Medline Industries, LP
- Operator Number
- 1417592
- Address
- Three Lakes Drive
- City
- Northfield
- State
- IL
- Postal Code
- 60093
- Country
- US
- Correspondent
- Stephanie Augsburg
US Agent
- Business Name
- Simcon International LLC
- Contact Name
- Rosanna Lee
- Address
- 1200 Townline Rd
- City
- Mundelein
- State
- IL
- ZIP
- 60060
- Country
- US
- [email protected]
- Phone
- 847 9492290
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2023-11-06 |
Proprietary Names
Two-Toned Bonded Gemini Sterilization Wrap
Medline Gemini Wrap
Establishment Types
Export Device to the United States But Perform No Other Operation on Device