| Primary Device ID | 00192896038776 |
| NIH Device Record Key | 809c4d12-ac49-425e-a829-217006d19d74 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BOUCHERON EAR SPECULA |
| Version Model Number | 465-210-2 |
| Catalog Number | 465-210-2 |
| Company DUNS | 040729840 |
| Company Name | SONTEC INSTRUMENTS, INC. |
| 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 | false |
| 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 |
| Phone | +1(800) 821-7496 |
| info@sontecinstruments.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896038776 [Primary] |
| HNC | Specula, ophthalmic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896038776]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-18 |
| Device Publish Date | 2018-09-17 |
| 00192896038813 | BOUCHERON EAR SPECULA SIZE 7 CHROME |
| 00192896038806 | BOUCHERON EAR SPECULA SIZE 6 CHROME |
| 00192896038790 | BOUCHERON EAR SPECULA SIZE 4 CHROME |
| 00192896038783 | BOUCHERON EAR SPECULA SIZE 3 CHROME |
| 00192896038776 | BOUCHERON EAR SPECULA SIZE 2 CHROME |
| 00192896038769 | BOUCHERON EAR SPECULA SIZE 1 CHROME |
| 00192896120426 | Boucheron Ear Specula Size 8 Chrome |