| Primary Device ID | M648C1002601 |
| NIH Device Record Key | 371301fd-c0f1-4a68-8097-baf239a7658b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ONETRAC LX |
| Version Model Number | C100260 |
| 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 | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M648C1002600 [Primary] |
| HIBCC | M648C1002601 [Package] Contains: M648C1002600 Package: BOX [1 Units] In Commercial Distribution |
| HIBCC | M648C1002602 [Package] Package: CASE [10 Units] In Commercial Distribution |
| GAD | Retractor |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-04-30 |
| Device Publish Date | 2020-04-22 |
| M648C1002402 | Retractor 90x20mm with Built-In Single-Use Multi-LED Light Source - STERILE |
| M648C1002302 | Retractor 90x60mm with Built-In Single-Use Multi-LED Light Source - STERILE |
| M648C1002202 | Retractor 175x30mm with Built-In Single-Use Multi-LED Light Source - STERILE |
| M648C1002102 | Retractor 135x30mm with Built-In Single-Use Multi-LED Light Source - STERILE |
| M648C1002601 | Retractor 135X60mm with Built-In Single-Use Multi-LED Light Source - STERILE |
| M648C1002901 | Retractor 135X20mm with Built-In Single-Use Multi-LED Light Source - STERILE |
| M648C1002801 | Retractor 90x30mm with Built-In Single-Use Multi-LED Light Source - STERILE |