| Primary Device ID | 46972011720111 |
| NIH Device Record Key | f3258f82-9a8a-4878-918f-df68728bde74 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EndoClot Applicator |
| Version Model Number | EA230 |
| Company DUNS | 544357082 |
| Company Name | EndoClot Plus Co.,Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 16972011720110 [Primary] |
| GS1 | 46972011720111 [Package] Contains: 16972011720110 Package: [5 Units] In Commercial Distribution |
| GCJ | Laparoscope, General & Plastic Surgery |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-01 |
| Device Publish Date | 2021-06-23 |
| 26972011720513 - EndoClot | 2022-03-28 EndoClot® Air Compressor Connecting Tube |
| 26972011720018 - EndoClot | 2022-03-23 EndoClot®Polysaccharide Hemostatic System, EndoClot® PHS |
| 26972011720247 - EndoClot SIS | 2021-11-24 EndoClot Submucosal Injection System |
| 26972011720254 - EndoClot SIS | 2021-11-24 EndoClot Submucosal Injection System |
| 26972011720025 - EndoClot PHS | 2021-07-01 |
| 26972011720032 - EndoClot PHS | 2021-07-01 |
| 46972011720111 - EndoClot Applicator | 2021-07-01 |
| 46972011720111 - EndoClot Applicator | 2021-07-01 |
| 26972011720223 - EndoClot | 2021-07-01 |