FDA Registration
Active
🇺🇸 United States
microdot 28g Lancet
Reg #: 3008700497
·
FEI: 3008700497
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Cambridge Sensors USA, LLC.
- Registration Number
- 3008700497
- FEI Number
- 3008700497
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 23866 W Industrial Dr N
- City
- Plainfield
- State
- IL
- ZIP
- 60585
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222376
Owner / Operator
- Firm Name
- Cambridge Sensors USA, LLC.
- Operator Number
- 10042320
- Address
- 23866 W Industrial Drive N
- City
- Plainfield
- State
- IL
- Postal Code
- 60585
- Country
- US
- Correspondent
- Chris W Sullivan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | Class 2 | General, Plastic Surgery | No | 2022-12-06 |
Proprietary Names
microdot 28g Lancet
microdot 23g 100ct Lancet
microdot 23g 200ct Lancet
microdot 21g Lancet
microdot 26g Lancet
microdot 30g Lancet
Establishment Types
Repack or Relabel Medical Device