FDA Registration
Active
🇺🇸 United States
SAFE N SIMPLE LLC
Reg #: 3008374791
·
FEI: 3008374791
·
Expires 2026
Products
14
Proprietary Names
0
Establishment Types
2
Classifications
14
Registration Details
- Registration Name
- SAFE N SIMPLE LLC
- Registration Number
- 3008374791
- FEI Number
- 3008374791
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 5827 Terex
- City
- Clarkston
- State
- MI
- ZIP
- 48346
- Country
- US
Regulatory Submissions
- 510(k) Number
- K160095
Owner / Operator
- Firm Name
- Safe N Simple LLC
- Operator Number
- 10033201
- Address
- 8112 Rosebud Lane
- City
- Clarkston
- State
- MI
- Postal Code
- 48348
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2018-05-31 |
| Support, Hernia | EXN | Class 1 | Gastroenterology, Urology | No | 2018-05-31 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2018-05-31 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2019-11-05 |
| Cement, Stomal Appliance, Ostomy | EZR | Class 1 | Gastroenterology, Urology | No | 2012-12-04 |
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2013-11-12 |
| Appliance, Colostomy, Disposable | EZS | Class 1 | Gastroenterology, Urology | No | 2012-12-04 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2014-01-16 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2018-05-31 |
| Bandage, Liquid, Skin Protectant | NEC | Class 1 | General Hospital | No | 2012-12-04 |
| Solvent, Adhesive Tape | KOX | Class 1 | General, Plastic Surgery | No | 2012-12-04 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2018-05-31 |
| Burn Kit Without Drug | OJJ | Class 1 | General, Plastic Surgery | No | 2018-05-31 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2019-10-16 |
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device