| Primary Device ID | 14897106954121 |
| NIH Device Record Key | 451f3935-ce0c-45fa-83d4-6ded5b4ddf46 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STOPCON Jet - Pentax® Auxiliary Water Connector for Pentax® 90/ i10 GI Endoscope |
| Version Model Number | EN10907B |
| Company DUNS | 686908512 |
| Company Name | GA Health Company Limited |
| 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 | false |
| 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 | 04897106954124 [Primary] |
| GS1 | 14897106954121 [Package] Contains: 04897106954124 Package: Box [100 Units] In Commercial Distribution |
| GS1 | 24897106954128 [Package] Package: Carton [10 Units] In Commercial Distribution |
| OCX | Endoscopic Irrigation/Suction System |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-08 |
| Device Publish Date | 2022-01-31 |