FDA Registration
Active
🇺🇸 United States
MSN10001 MSN10002 MSN10003 MSN10004 MSN10005 MSN10006 MSN10007 Cannulated Countersinks
Reg #: 1828288
·
FEI: 1828288
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ORCHID UNIQUE
- Registration Number
- 1828288
- FEI Number
- 1828288
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6688 Dixie Hwy
- City
- Bridgeport
- State
- MI
- ZIP
- 48722
- Country
- US
Regulatory Submissions
- 510(k) Number
- K130319
Owner / Operator
- Firm Name
- Unique Instruments Inc.
- Operator Number
- 10042005
- Address
- 6688 Dixie Hwy
- City
- Bridgeport
- State
- MI
- Postal Code
- 48722
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2018-11-06 |
Proprietary Names
MSN10001 MSN10002 MSN10003 MSN10004 MSN10005 MSN10006 MSN10007 Cannulated Countersinks
MSN10009 MSN20001 MSN20002 MSN20003 MSN20004 MSN20005 MSN20006 MSN20007 MSN20008 MSN20009 Cannulated Countersinks
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)