| Primary Device ID | M648C1102001 |
| NIH Device Record Key | a82a0ba8-def4-4a97-9932-31a8f74a0a67 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ONETRAC LXS |
| Version Model Number | C110200 |
| Catalog Number | C110200 |
| Company DUNS | 011560431 |
| Company Name | OBP CORPORATION |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M648C1102000 [Primary] |
| HIBCC | M648C1102001 [Package] Contains: M648C1102000 Package: BOX [1 Units] In Commercial Distribution |
| HIBCC | M648C1102002 [Package] Package: CARTON [10 Units] In Commercial Distribution |
| JOL | Catheter And Tip, Suction |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-20 |
| Device Publish Date | 2021-04-12 |
| M648C1102001 | ONETRAC LXS SUCTION, CROWN TIP, WITH BUILT IN RADIAL LIGHT SOURCE, SINGLE USE - STERILE |
| M648C1102201 | ONETRAC LXS SUCTION, TAPER TIP, WITH BUILT IN RADIAL LIGHT SOURCE, SINGLE USE - STERILE |
| M648C1102101 | ONETRAC LXS SUCTION, METAL TIP, WITH BUILT IN RADIAL LIGHT SOURCE, SINGLE USE - STERILE |