| Primary Device ID | 06959385794315 |
| NIH Device Record Key | df894695-6d8b-4bc9-8d3b-39b1af5e0c54 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BGEcare Sterile Non-woven Island Dressing |
| Version Model Number | ID0404015012S |
| Company DUNS | 654591569 |
| Company Name | Zhende Medical Co., Ltd. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06959385794308 [Primary] |
| GS1 | 06959385794315 [Package] Contains: 06959385794308 Package: box [50 Units] In Commercial Distribution |
| GS1 | 06959385794322 [Package] Package: carton box [12 Units] In Commercial Distribution |
| NAC | Dressing, Wound, Hydrophilic |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[06959385794315]
Radiation Sterilization
[06959385794315]
Radiation Sterilization
[06959385794315]
Radiation Sterilization
[06959385794315]
Radiation Sterilization
[06959385794315]
Radiation Sterilization
[06959385794315]
Radiation Sterilization
[06959385794315]
Radiation Sterilization
[06959385794315]
Radiation Sterilization
[06959385794315]
Radiation Sterilization
[06959385794315]
Radiation Sterilization
[06959385794315]
Radiation Sterilization
[06959385794315]
Radiation Sterilization
[06959385794315]
Radiation Sterilization
[06959385794315]
Radiation Sterilization
[06959385794315]
Radiation Sterilization
[06959385794315]
Radiation Sterilization
[06959385794315]
Radiation Sterilization
[06959385794315]
Radiation Sterilization
[06959385794315]
Radiation Sterilization
[06959385794315]
Radiation Sterilization
[06959385794315]
Radiation Sterilization
[06959385794315]
Radiation Sterilization
[06959385794315]
Radiation Sterilization
[06959385794315]
Radiation Sterilization
[06959385794315]
Radiation Sterilization
[06959385794315]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-15 |
| Device Publish Date | 2021-03-05 |
| 06959385794346 | BGEcare Sterile Non-woven Island Dressing, 4"X4", 1 pieces/pack, 50 packs/box, 12 boxes/carton b |
| 06959385794315 | BGEcare Sterile Non-woven Island Dressing, 4''X4'', 1 pieces/pack, 50 packs/box, 12 boxes/carton |