| Primary Device ID | 06972403300602 |
| NIH Device Record Key | b93083c6-fa76-4e7a-8a42-9d01c0493db7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BGEcare Sterile Lap Sponge |
| Version Model Number | LS041818040540S |
| Company DUNS | 528104096 |
| Company Name | Xuchang Zhende Surgical Dressing 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 | 06972403300596 [Primary] |
| GS1 | 06972403300602 [Package] Contains: 06972403300596 Package: carton box [40 Units] In Commercial Distribution |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[06972403300602]
Ethylene Oxide
[06972403300602]
Ethylene Oxide
[06972403300602]
Ethylene Oxide
[06972403300602]
Ethylene Oxide
[06972403300602]
Ethylene Oxide
[06972403300602]
Ethylene Oxide
[06972403300602]
Ethylene Oxide
[06972403300602]
Ethylene Oxide
[06972403300602]
Ethylene Oxide
[06972403300602]
Ethylene Oxide
[06972403300602]
Ethylene Oxide
[06972403300602]
Ethylene Oxide
[06972403300602]
Ethylene Oxide
[06972403300602]
Ethylene Oxide
[06972403300602]
Ethylene Oxide
[06972403300602]
Ethylene Oxide
[06972403300602]
Ethylene Oxide
[06972403300602]
Ethylene Oxide
[06972403300602]
Ethylene Oxide
[06972403300602]
Ethylene Oxide
[06972403300602]
Ethylene Oxide
[06972403300602]
Ethylene Oxide
[06972403300602]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-19 |
| Device Publish Date | 2021-03-11 |
| 06972403300626 | BGEcare Sterile Lap Sponge 18"X18", 4-Ply, 5 pieces/pack, 10 packs/box, 4 boxes/carton box |
| 06972403300602 | BGEcare Sterile Lap Sponge 18"X18", 4-Ply, 5 pieces/pack, 40 packs/carton box |