FDA Registration
Inactive
🇺🇸 United States
GENTEEL, LLC
·
Expires 2026
Products
1
Proprietary Names
2
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- GENTEEL, LLC
- Status
- Inactive
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2904 Rawhide St
- City
- West Linn
- State
- OR
- ZIP
- 97068
- Country
- US
Regulatory Submissions
- 510(k) Number
- K153670
Owner / Operator
- Firm Name
- Genteel, LLC
- Operator Number
- 10095620
- Address
- 2904 Rawhide Street
- City
- West Linn
- State
- OR
- Postal Code
- 97068
- Country
- US
- Correspondent
- Christopher Jacobs
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 | 2026-04-03 |
Proprietary Names
GENTEEL BUTTERFLY TOUCH LANCETS
GENTEEL LANCING DEVICE
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility