FDA Registration
Active
🇺🇸 United States
Apex Aseptic Products
Reg #: 3019458442
·
FEI: 3019458442
·
Expires 2026
Products
7
Proprietary Names
1
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- Apex Aseptic Products
- Registration Number
- 3019458442
- FEI Number
- 3019458442
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2 Executive Drive
- City
- Voorhees
- State
- NJ
- ZIP
- 08043
- Country
- US
Regulatory Submissions
- 510(k) Number
- K040333
Owner / Operator
- Firm Name
- MaxCare Products, LLC
- Operator Number
- 10075148
- Address
- 102 Queens Drive
- City
- King of Prussia
- State
- PA
- Postal Code
- 19406
- Country
- US
- Correspondent
- Janet Jia
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2020-08-04 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-08-04 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2020-08-04 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-08-04 |
| Suit, Surgical | FXO | Class 1 | General, Plastic Surgery | No | 2020-08-04 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2020-08-04 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2020-09-25 |
Proprietary Names
Apex Aseptic / AseptiCor / AsViro / MaxCare / Denline
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility