| Primary Device ID | 00850040140002 |
| NIH Device Record Key | 681affa2-6afe-417a-a8f6-3300e0bb9925 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LXS STYLET |
| Version Model Number | C110204 |
| Company DUNS | 118262590 |
| Company Name | OBP Surgical 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 | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850040140002 [Primary] |
| GAH | Stylet, 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 | 2024-07-16 |
| Device Publish Date | 2024-07-08 |
| 00850040140002 - LXS STYLET | 2024-07-16Flexible stylet (accessory) to be used with the ONETRAC LXS Yankauer suction cannula |
| 00850040140002 - LXS STYLET | 2024-07-16 Flexible stylet (accessory) to be used with the ONETRAC LXS Yankauer suction cannula |
| 00850040140453 - ONETRAC LXS | 2023-07-31 ONETRAC LXS single-use suction device with integrated cordless radial LED light source, Frazier, 8 Fr |
| 00850040140460 - ONETRAC LXS | 2023-07-31 ONETRAC LXS single-use suction device with integrated cordless radial LED light source, Frazier, 12 Fr |