| Primary Device ID | 06972403420164 |
| NIH Device Record Key | 0f9a4b16-82b7-4b92-92c9-7bcddc9c6c9a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BGEcare Non-sterile Non-woven Sponge |
| Version Model Number | NS0603030420020NS |
| Company DUNS | 544509489 |
| Company Name | Henan Zhende Medical Products 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 | 06972403420157 [Primary] |
| GS1 | 06972403420164 [Package] Contains: 06972403420157 Package: carton box [20 Units] In Commercial Distribution |
| FRL | Fiber, Medical, Absorbent |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-16 |
| Device Publish Date | 2021-03-08 |
| 06972403420218 | BGEcare Non-sterile Non-woven Sponge 2"X2", 4-Ply, 200 pieces/pack, 20 packs/carton box |
| 06972403420164 | BGEcare Non-sterile Non-woven Sponge 3"X3", 4-Ply, 200 pieces/pack, 20 packs/carton box |
| 06972403420140 | BGEcare Non-sterile Non-woven Sponge 4"X4", 4-Ply, 200 pieces/pack, 10 packs/carton box |