| Primary Device ID | 14897106953483 |
| NIH Device Record Key | 1982ef22-f4b6-46f3-af7d-21c07fefe1cc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PearlCatch™ Single Chamber Polyp Trap |
| Version Model Number | GAR014 |
| Company DUNS | 686908512 |
| Company Name | GA Health Company Limited |
| Device Count | 1 |
| DM Exempt | false |
| 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 | 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 | 04897106950546 [Previous] |
| GS1 | 04897106953486 [Primary] |
| GS1 | 14897106953483 [Package] Contains: 04897106953486 Package: Box [50 Units] In Commercial Distribution |
| GS1 | 24897106953480 [Package] Contains: 04897106953486 Package: Cartoon [100 Units] In Commercial Distribution |
| CBC | Bottle, Collection And Trap, Breathing System (Uncalibrated) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-18 |
| Device Publish Date | 2020-12-10 |