| Primary Device ID | 06926515473655 |
| NIH Device Record Key | 63322629-820b-4dab-8aa9-5c30df0f53ca |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BGE |
| Version Model Number | FDNA0404011020S |
| Company DUNS | 654591569 |
| Company Name | Zhende 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 | true |
| 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 | 06926515473648 [Primary] |
| GS1 | 06926515473655 [Package] Contains: 06926515473648 Package: box [10 Units] In Commercial Distribution |
| GS1 | 06926515473662 [Package] Package: case [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 | 2023-07-14 |
| Device Publish Date | 2023-07-06 |
| 06926515473716 | Window-Frame Transparent Dressing 10×10cm 1 ea/pk, 100 ea/bx,16 bx/cs |
| 06926515473686 | Super Absorbent dressing 10×10cm 1 ea/pk, 10 ea/bx,20 bx/cs |
| 06926515473655 | Foam dressing non adhesive 10×10cm 1 ea/pk, 10 ea/bx, 20 bx/cs |
| 06926515473624 | Foam dressing adhesive 10×10cm 1 ea/pk, 10 ea/bx, 20 bx/cs |
| 06926515473594 | Silicone foam dressing Non border 10×10cm 1 ea/pk, 10 ea/bx, 20 bx/cs |