| Primary Device ID | 10818614020492 |
| NIH Device Record Key | c68134db-7e90-4d44-b7d0-7aea4b597d6f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tri-Gate Disposable Cannula |
| Version Model Number | 00-6570 |
| Company DUNS | 117630237 |
| Company Name | Maruho Medical, 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 | 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 | 00818614020495 [Primary] |
| GS1 | 10818614020492 [Package] Contains: 00818614020495 Package: Box [6 Units] In Commercial Distribution |
| GEA | Cannula, Surgical, General & Plastic Surgery |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-18 |
| Device Publish Date | 2022-05-10 |
| 10818614020546 | 8.5 ID x 90mm Tri-Gate Disposable Cannula |
| 10818614020539 | 7.5 ID x 90mm Tri-Gate Disposable Cannula |
| 10818614020522 | 6.5 ID x 90mm Tri-Gate Disposable Cannula |
| 10818614020515 | 8.5 ID x 70mm Tri-Gate Disposable Cannula |
| 10818614020508 | 7.5 ID x 70mm Tri-Gate Disposable Cannula |
| 10818614020492 | 6.5 ID x 70mm Tri-Gate Disposable Cannula |