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 |