| Primary Device ID | 06972403301111 |
| NIH Device Record Key | 74b27637-82b5-42af-9733-05b1a3cc51b2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BGEcare Sterile Gauze Sponge |
| Version Model Number | GS01030312024030S |
| 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 | 06972403301104 [Primary] |
| GS1 | 06972403301111 [Package] Contains: 06972403301104 Package: box [40 Units] In Commercial Distribution |
| GS1 | 06972403301128 [Package] Package: carton box [30 Units] In Commercial Distribution |
| NAB | Gauze / Sponge,Nonresorbable For External Use |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
Ethylene Oxide
[06972403301111]
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 |
| 06972403301142 | BGEcare Sterile Gauze Sponge 4''X4'', 12-Ply, 2 pieces/pack,25 packs/box, 24 boxes/carton box |
| 06972403301111 | BGEcare Sterile Gauze Sponge 3''X3'', 12-Ply, 2 pieces/pack, 40 packs/box, 30 boxes/carton box |
| 06972403301081 | BGEcare Sterile Gauze Sponge 2''X2'', 12-Ply, 2 pieces/pack, 50 packs/box, 45 boxes/carton box |
| 06972403301050 | BGEcare Sterile Gauze Sponge 4''X4'', 8-Ply, 2 pieces/pack, 50 packs/box, 12 boxes/carton box |
| 06972403301029 | BGEcare Sterile Gauze Sponge 3''X3'', 8-Ply, 2 pieces/pack, 50 packs/box, 24 boxes/carton box |
| 06972403300992 | BGEcare Sterile Gauze Sponge 2''X2'', 8-Ply, 2 pieces/pack, 50 packs/box, 30 boxes/carton box |
| 06972403300497 | BGEcare Sterile Gauze Sponge 4''X4'', 8-Ply, 2 pieces/pack, 50 packs/box, 12 boxes/carton box |