| Primary Device ID | 14897106954107 |
| NIH Device Record Key | bf61959a-79de-4372-8783-56013ebd6537 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STOPCON Biopsy Valve For Pentax® GI-Endoscope |
| Version Model Number | EN10234B |
| 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 | 04897106954100 [Primary] |
| GS1 | 14897106954107 [Package] Contains: 04897106954100 Package: Box [100 Units] In Commercial Distribution |
| GS1 | 24897106954104 [Package] Package: Carton [4 Units] In Commercial Distribution |
| ODC | Endoscope Channel Accessory |
| 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 |