FDA Registration
Active
🇺🇸 United States
PRIME DISTRIBUTORS LLC
Reg #: 3004585750
·
FEI: 3004585750
·
Expires 2026
Products
7
Proprietary Names
0
Establishment Types
1
Classifications
7
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Registration Details
- Registration Name
- PRIME DISTRIBUTORS LLC
- Registration Number
- 3004585750
- FEI Number
- 3004585750
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1769 48th St
- City
- BROOKLYN
- State
- NY
- ZIP
- 11204
- Country
- US
Regulatory Submissions
- 510(k) Number
- K042275
Owner / Operator
- Firm Name
- PRIME DISTRIBUTORS LLC
- Operator Number
- 9063520
- Address
- 1769 48th St., --
- City
- Brooklyn
- State
- NY
- Postal Code
- 11204
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2004-05-14 |
| Lens, Contact, (Disposable) | MVN | Class 2 | Ophthalmic | No | 2007-03-01 |
| Lenses, Soft Contact, Daily Wear | LPL | Class 2 | Ophthalmic | No | 2007-03-01 |
| Pad, Menstrual, Unscented | HHD | Class 1 | Obstetrics/Gynecology | No | 2005-03-03 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2007-05-02 |
| Floss, Dental | JES | Class 1 | Dental | No | 2017-02-12 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2006-06-06 |
Establishment Types
Repack or Relabel Medical Device