FDA Registration
Active
🇺🇸 United States
ALLOGEL
Reg #: 3015729128
·
FEI: 3015729128
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- GEL-X LLC
- Registration Number
- 3015729128
- FEI Number
- 3015729128
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 251 Little Falls Dr
- City
- Wilmington
- State
- DE
- ZIP
- 19808
- Country
- US
Regulatory Submissions
- 510(k) Number
- K110102
Owner / Operator
- Firm Name
- GEL-X LLC
- Operator Number
- 10060658
- Address
- 251 Little Falls Drive
- City
- Wilmington
- State
- DE
- Postal Code
- 19808
- Country
- US
- Correspondent
- Andreas Brown
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2019-07-18 |
Proprietary Names
ALLOGEL
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility