This page includes the latest FDA filings for Polyzen Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 1064859 |
| FEI Number | 3002897588 |
| Name | POLYZEN, INC. |
| Owner & Operator | POLYZEN, INC. |
| Contact Address | 1041 CLASSIC ROAD -- Apex NC 27539 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 1041 CLASSIC ROAD APEX, NC 27539 US |
| Establishment Type | Manufacture Medical Device for Another Party (Contract Manufacturer) |
Device Company | Device | Date |
|---|---|---|
POLYZEN, INC. | Pure-Vu? Oversleeve Standard, (5 pack) | 2019-09-03 |
POLYZEN, INC. | Pure-Vu? Oversleeve SLIM, (5 pack) | 2019-09-03 |
POLYZEN, INC. | Pure-Vu Slim System | 2018-10-04 |
POLYZEN, INC. | Pure-Vu System | 2018-02-07 |
POLYZEN, INC. | FlexTEMP System, Jacket - 989803178181 | 2014-06-05 |
| NCAGE Code | 3E4Y3 | POLYZEN INC |
| CAGE Code | 3E4Y3 | POLYZEN INC |
| DUNS | 002800345 | POLYZEN INC |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2020071466666 | Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey | PLASTIC GRANULES | 1 SKD |
| 2020061959623 | Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey | PLASTIC GRANULES | 1 SKD |
| 2019020226308 | Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey | MEDICAL SUPPLIES HTS 392390 | 2 PCS |
| 2019012443646 | Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey | MEDICAL SUPPLIES HTS 392390 | 2 PCS |
| 2018122464946 | Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | MEDIPRENE TPE COMPOUND | 2 PKG |
| 2018111432441 | Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey | MEDICAL EQUIP AND SUPPLIES HS CODE : 392390 | 40 PKG |
| 2018110660119 | Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey | MEDICAL EQUIP AND SUPPLIES HS CODE : 392390 | 40 PKG |
| 2018082716997 | Rotterdam,Netherlands -> Los Angeles, California | MEDICAL EQUIP AND SUPPLIES HS CODE 392390 | 3 PCS |