| Primary Device ID | 00877972000334 |
| NIH Device Record Key | d2cc7ca3-7754-4ce3-a0a4-a1c62190f015 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kit |
| Version Model Number | 120-105-192 |
| Company DUNS | 079805400 |
| Company Name | GENICON, INC. |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00877972000334 [Primary] |
| GEA | Cannula, Surgical, General & Plastic Surgery |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-01-09 |
| Device Publish Date | 2017-05-05 |
| 00877972000334 - Kit | 2020-01-09 |
| 00877972000334 - Kit | 2020-01-09 |
| 00877972000426 - GeniShield | 2020-01-09 |
| 00877972000433 - GeniShield | 2020-01-09 |
| 00877972000440 - GeniShield | 2020-01-09 |
| 00877972000464 - GeniShield | 2020-01-09 |
| 00877972000471 - GeniShield | 2020-01-09 |
| 00877972000488 - GeniShield | 2020-01-09 |
| 00877972000495 - GeniPort | 2020-01-09 |