| Primary Device ID | 06926515473686 | 
| NIH Device Record Key | 0310f547-0373-45f0-831e-b14069e4920e | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | BGE | 
| Version Model Number | SFDNB0404011020S | 
| 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 | 06926515473679 [Primary] | 
| GS1 | 06926515473686 [Package] Contains: 06926515473679 Package: box [10 Units] In Commercial Distribution | 
| GS1 | 06926515473693 [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 |