Primary Device ID | 26958868742090 |
NIH Device Record Key | a51026d1-0e39-4a36-a61e-3fe91f6c715c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Polynew |
Version Model Number | 5cm×5cm |
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 | 16958868742093 [Primary] |
GS1 | 26958868742090 [Package] Contains: 16958868742093 Package: box [12 Units] In Commercial Distribution |
GS1 | 36958868742097 [Package] Package: box [120 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 |