FDA Registration
Active
🇺🇸 United States
ENTROTECH LIFE SCIENCES, LLC
Reg #: 3009134884
·
FEI: 3011393407
·
Expires 2026
Products
4
Proprietary Names
9
Establishment Types
4
Classifications
4
Registration Details
- Registration Name
- ENTROTECH LIFE SCIENCES, LLC
- Registration Number
- 3009134884
- FEI Number
- 3011393407
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1245 Kinnear Road
- City
- Columbus
- State
- OH
- ZIP
- 43212
- Country
- US
Regulatory Submissions
- 510(k) Number
- K140389
Owner / Operator
- Firm Name
- entrotech life sciences, llc
- Operator Number
- 10088716
- Address
- 1245 Kinnear Road
- City
- Columbus
- State
- OH
- Postal Code
- 43212
- Country
- US
- Correspondent
- George J Holinga
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2023-10-04 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2023-10-04 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2023-10-04 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2023-10-04 |
Proprietary Names
Battle Wrap
Sentinel ChestSeal
PrevahexCHX 1492CH
PrevahexCHX 1483CH
PrevahexCHX 1485CH
PrevahexCHX 1491CH
PrevahexCHX 1484CH
Multi-T 2021KB
Multi-T 2021KS
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198