| Primary Device ID | 00852306007302 |
| NIH Device Record Key | f2c1f18c-f97a-4881-b282-1d4b8425d2c4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FlexGuide ULTRA with Tray |
| Version Model Number | FLEX-ULTRA SET |
| Catalog Number | FLEX-ULTRA SET |
| Company DUNS | 030124221 |
| Company Name | OMNIGUIDE, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852306007302 [Primary] |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00852306007302]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-22 |
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