FDA Registration
Active
🇹🇷 Türkiye
Endo GIA Tm Reinforced Reload with Tn-Staple Tm Technology
Reg #: 3014479313
·
FEI: 3014479313
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET LIMITED SIRKETI
- Registration Number
- 3014479313
- FEI Number
- 3014479313
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- NO:4 MIMAR SINAN MAHALLESI NAMIK KEMAL CADDESI AYDIN SOKAK, ATASEHIR 34762, Istanbul (Anatolia) Turkey
- City
- Istanbul
- Country
- TR
Regulatory Submissions
- 510(k) Number
- K111825
Owner / Operator
- Firm Name
- SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET LIMITED SIRKETI
- Operator Number
- 10089530
- Address
- NO:4 MIMAR SINAN MAHALLESI NAMIK KEMAL CADDESI AYDIN SOKAK, ATASEHIR 34762, Istanbul (Anatolia) Turkey
- City
- Istanbul
- State
- TR-34
- Postal Code
- 34758
- Country
- TR
US Agent
- Business Name
- Liberty Management Group Ltd.
- Contact Name
- Manoj Zacharias
- Address
- 75 Executive Drive,, Suite 114,
- City
- Aurora
- State
- IL
- ZIP
- 60504
- Country
- US
- [email protected]
- Phone
- 630 2702921
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2024-03-27 |
Proprietary Names
Endo GIA Tm Reinforced Reload with Tn-Staple Tm Technology
Covidien Endo GIA Ultra Universal stapler
ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS
DST SERIES(TM) TA(TM) STAPLERS
Establishment Types
Export Device to the United States But Perform No Other Operation on Device