| Primary Device ID | 00860002476155 |
| NIH Device Record Key | 6c37bb15-571b-4535-a651-ed5b5d65d7e0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Occlusion Disc |
| Version Model Number | OD-1 |
| Catalog Number | OD-1 |
| Company DUNS | 005875146 |
| Company Name | GRI MEDICAL PRODUCTS INC |
| 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 | true |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 800-291-9425 |
| snider@grimedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860002476155 [Primary] |
| KQT | Evacuator, Gastro-Urology |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-12-26 |
| Device Publish Date | 2019-12-18 |
| 00860002476100 - Intussusception Air Reduction Kit with Blue tip | 2019-12-26 Intussusception Air Reduction Kit with Pink Tip |
| 00860002476117 - Intussusception Air Reduction Kit with Pink Tip | 2019-12-26 Intussusception Air Reduction Kit with Pink Tip |
| 00860002476124 - Intussusception Air Reduction kit, no tip | 2019-12-26 Intussusception Air Reduction kit, no tip |
| 00860002476131 - Intussusception Air Reduction Bulb & Gauge | 2019-12-26 Intussusception Air Reduction Bulb & Gauge |
| 00860002476148 - Intussusception Air Reduction Bulb & Gauge with Plastic Case | 2019-12-26 Intussusception Air Reduction Bulb & Gauge with Plastic Case |
| 00860002476155 - Occlusion Disc | 2019-12-26Occlusion Disc, Silicone |
| 00860002476155 - Occlusion Disc | 2019-12-26 Occlusion Disc, Silicone |
| 00860002476162 - Intussusception Pressure Relief Valve | 2019-12-26 Intussusception Pressure Relief Valve |