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 |