| Primary Device ID | 00860003986868 |
| NIH Device Record Key | 67be62d0-3e76-4ec4-a98c-63f8dac7e796 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GENESIS BI-WING AAP, XL |
| Version Model Number | FPLS-2100 |
| Catalog Number | FPLS-2100 |
| Company DUNS | 079575412 |
| Company Name | Infinitus Medical Technologies LLC |
| 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 | false |
| 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 | 00860003986868 [Primary] |
| CCX | Support, Patient Position |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-25 |
| Device Publish Date | 2024-07-17 |
| 00195893257713 - GENESIS BI-WING AAP | 2024-07-25 |
| 00195893509492 - VISIWRAP SURGICAL FACE PROTECTOR | 2024-07-25 |
| 00860003986868 - GENESIS BI-WING AAP, XL | 2024-07-25 |
| 00860003986868 - GENESIS BI-WING AAP, XL | 2024-07-25 |
| 00860003986875 - HADRON FPLS INFINITY | 2024-07-25 |
| 00860003986882 - HADRON FPLS INFINITY, HDP | 2024-07-25 |
| 00860003986899 - HADRON FPLS INFINITY, XL | 2024-07-25 |
| 00860006375904 - KYBER SCC OFFSET UNIVERSAL RETRACTION POST SYSTEM | 2024-07-25 |
| 00860006375911 - ION ESPS ARM FIXATION SYSTEM | 2024-07-25 |