| Primary Device ID | 06972403300657 |
| NIH Device Record Key | 12554eb1-0d31-4c8f-99bf-c164c8e01617 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BGEcare Sterile OR Towel |
| Version Model Number | OT051723010420S |
| 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 | 06972403300640 [Primary] |
| GS1 | 06972403300657 [Package] Contains: 06972403300640 Package: carton box [20 Units] In Commercial Distribution |
| FRL | Fiber, Medical, Absorbent |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[06972403300657]
Ethylene Oxide
[06972403300657]
Ethylene Oxide
[06972403300657]
Ethylene Oxide
[06972403300657]
Ethylene Oxide
[06972403300657]
Ethylene Oxide
[06972403300657]
Ethylene Oxide
[06972403300657]
Ethylene Oxide
[06972403300657]
Ethylene Oxide
[06972403300657]
Ethylene Oxide
[06972403300657]
Ethylene Oxide
[06972403300657]
Ethylene Oxide
[06972403300657]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-16 |
| Device Publish Date | 2021-03-08 |
| 06972403307717 - CardinalHealth | 2023-07-07 X-Ray Detectable Laparotomy Sponges |
| 06972403307564 - ZD | 2023-07-06 Alcohol prep pad 1.1875 x 1.35 in |
| 06972403307601 - Cardinal Health | 2023-07-06 SurgicalTowel BLUE 17 x 23 in.4000 each per case |
| 06972403300497 - BGEcare Sterile Gauze Sponge | 2021-03-19 BGEcare Sterile Gauze Sponge 4''X4'', 8-Ply, 2 pieces/pack, 50 packs/box, 12 boxes/carton box |
| 06972403300541 - BGEcare Non-sterile Gauze Sponge | 2021-03-19 BGEcare Non-sterile Gauze Sponge 4''X4'', 12-Ply, 200 pieces/pack,10 packs/carton box |
| 06972403300565 - BGEcare Non-sterile Gauze Sponge | 2021-03-19 BGEcare Non-sterile Gauze Sponge 4''X4'', 12-Ply, 200 pieces/pack,20 packs/carton box |
| 06972403300602 - BGEcare Sterile Lap Sponge | 2021-03-19 BGEcare Sterile Lap Sponge 18"X18", 4-Ply, 5 pieces/pack, 40 packs/carton box |
| 06972403300916 - BGEcare Non-sterile Gauze Sponge | 2021-03-19 BGEcare Non-sterile Gauze Sponge 2''X2'', 8-Ply, 200 pieces/pack,25 packs/carton box |