FDA Registration
Active
🇵🇦 Panama
Medline Panama LLC S. de R.L.
Reg #: 3016761372
·
FEI: 3016761372
·
Expires 2026
Products
6
Proprietary Names
33
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Medline Panama LLC S. de R.L.
- Registration Number
- 3016761372
- FEI Number
- 3016761372
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Panama-Pacifico, Boulevard Panama Pacifico, International Business Park, Building 3855, Office 209
- City
- Veracruz, Arraijan Panama
- Country
- PA
Regulatory Submissions
- 510(k) Number
- K220365
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 | 2022-11-07 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2008-11-20 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2008-11-20 |
| Cover, Barrier, Protective | MMP | Class 2 | General, Plastic Surgery | No | 2010-11-10 |
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2019-02-28 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2017-08-25 |
Proprietary Names
Gemini
Medline
Medline surgical kits/trays and CDS modules
MEDLINE General surgery tray (kit)
Medline / Eclipse / Aurora / Sirus surgical packs
Convenience Trays & Kits CSTM
Medline Proxima
170019-Convenience Trays & Kits CSTM
Medline General Surgery Tray
Medline Basin Tray
Eclipse Surgical Pack
Aurora Surgical Pack
Sirus Surgical Pack
Eclipse Surgical Drape
Medline Surgical Drape
Medline Keyboard Cover
Medline Band Bag
Medline Set Up Cover
Vari-Lens
Lingeman
Procept
AKTORmed
Microtek Patient Drapes
Medline Dome Bag
Convertors
Vital Care
Perfect Pouch
OnLume
Medline Poly-lined Drape
Medline Poly-lined Fenestrated Drape
Medline Equipment Cover
Microtek Probe Cover
Microtek Equipment Drapes
Establishment Types
Export Device to the United States But Perform No Other Operation on Device