FDA Registration
Active
🇺🇸 United States
TRAY, UDEL, FLEXIBLE FIBERSCOPES
Reg #: 1221053
·
FEI: 1221053
·
Expires 2025
Products
1
Proprietary Names
19
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SYMMETRY MEDICAL, INC. - MANCHESTER
- Registration Number
- 1221053
- FEI Number
- 1221053
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 253 Abby Rd
- City
- MANCHESTER
- State
- NH
- ZIP
- 03103
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201945
Owner / Operator
- Firm Name
- Tecomet
- Operator Number
- 1828464
- Address
- 170 New Boston Street, --
- City
- Woburn
- State
- MA
- Postal Code
- 01801
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2021-08-31 |
Proprietary Names
TRAY, UDEL, FLEXIBLE FIBERSCOPES
TRAY, UDEL, 1 RIGID SCOPE 10MM X 33CM
TRAY, UDEL, INLINE/C-MOUNT CAMERA HEADS
TRAY, UDEL, 2 RIGID SCOPES 4MM X 30CM
TRAY, UDEL, 1 RIGID SCOPE 4MM X 30CM
TRAY, UDEL, 2 RIGID SCOPES/CABLE
TRAY, UDEL, STANDARD CAMERA HEADS
TRAY, UDEL 2 RIGID SCOPES 10MM X 33CM
TRAY, UDEL, FLEXIBLE FIBERSCOPE
TRAY, UDEL, FLEXIBLE CMOS VIDEOSCOPES
TRAY, UDEL, FLEXIBLE CCD VIDEOSCOPES
TRAY, UDEL, 4 RIGID SCOPES/CABLE
TRAY, UDEL, INLINE CAMERA HEADS
TRAY, UDEL, PENDULUM/INLINE CAM HEADS
TRAY, UDEL, 2 RIGID SCOPES 4MM X 18CM
Karl Storz Udel Sterilization Trays
TRAY, UDEL, 2 RIGID SCOPES 5.5MM X 33CM
TRAY, UDEL, 2 RIGID SCOPES 5.5MM X 53CM
TRAY, UDEL, RIGID 10MMX33CM SCOPE/CABLE
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)