FDA Registration
Active
🇩🇪 Germany
CamX Triton HD Camera Sheath
Reg #: 3001052305
·
FEI: 3001052305
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Durr Optronik GmbH & Co. KG
- Registration Number
- 3001052305
- FEI Number
- 3001052305
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Gultlinger Str. 14
- City
- Gechingen Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K132953
Owner / Operator
- Firm Name
- DURR DENTAL SE
- Operator Number
- 10047925
- Address
- Hopfigheimer Str. 17
- City
- Bietigheim-Bissingen
- State
- Baden-Wurttemberg
- Postal Code
- 74321
- Country
- DE
- Correspondent
- Oliver Lange
US Agent
- Business Name
- Air Techniques, Inc.
- Contact Name
- Joseph Latkowski
- Address
- 1295 Walt Whitman Rd
- City
- Melville
- State
- NY
- ZIP
- 11747
- Country
- US
- [email protected]
- Phone
- 516 2145574
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dental Barriers And Sleeves | PEM | Class 2 | General, Plastic Surgery | No | 2019-07-01 |
Proprietary Names
CamX Triton HD Camera Sheath
Establishment Types
Repack or Relabel Medical Device