| Primary Device ID | 07640178989139 |
| NIH Device Record Key | f8232496-c851-4155-a3b7-af282060b52c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OTELO MIS-Instruments |
| Version Model Number | OTO-BX 20 02-N |
| Catalog Number | OTO-BX 20 02-N |
| Company DUNS | 483016148 |
| Company Name | SpineArt SA |
| 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 | 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 | 07640178989139 [Primary] |
| FSM | Tray, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
[07640178989139]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-02 |
| Device Publish Date | 2021-03-25 |
| 07640178982390 | DILATOR NEEDLE BLUNT |
| 07640178989160 | INSERT |
| 07640178989146 | INSERT |
| 07640178989139 | INSERT |
| 07640178989122 | INSTRUMENT BOX |