| Primary Device ID | 26958868748023 |
| NIH Device Record Key | e707ab92-98b7-4262-a050-eee742e7f4f3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Polynew |
| Version Model Number | 10cm×10cm |
| Company DUNS | 527587815 |
| Company Name | Roosin Medical Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 16958868748026 [Primary] |
| GS1 | 26958868748023 [Package] Contains: 16958868748026 Package: box [12 Units] In Commercial Distribution |
| GS1 | 36958868748020 [Package] Package: box [20 Units] In Commercial Distribution |
| NAD | Dressing, Wound, Occlusive |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-03 |
| Device Publish Date | 2022-09-23 |
| 26958868748023 | Silicone Foam Dressing 10cm×10cm |
| 16958868746015 | Silver Calcium Alginate Dressing 10cm×10cm |
| 26958868744018 | Island dressing 10cm×10cm |
| 26958868743011 | Hydrocolloid Wound Dressing 10cm×10cm |
| 26958868742090 | Honey Calcium Alginate Dressing 5cm×5cm |
| 26958868742014 | Honey Gauze Dressing 5cm×5cm |
| 26958868741017 | Foam Dressing 10cm×10cm |
| 26958868740010 | Calcium Alginate Wound Dressing 10cm×10cm |
| 26958868742175 | Honey Gauze Dressing 10cm×10cm |
| 26958868747057 | Xeroform Petrolatum Dressing 5cm×5cm |
| 26958868747040 | Xeroform Petrolatum Dressing 2.5cm×20cm |
| 26958868743059 | Hydrocolloid dressing 5cm×7.5cm |
| 26958868743042 | Hydrocolloid dressing 5cm×5cm |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() POLYNEW 90184094 not registered Live/Pending |
POLYX INC. 2020-09-16 |