Primary Device ID | 06973919590075 |
NIH Device Record Key | 21cd9793-775e-486a-87f8-4f0b27b611bc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Otoscope |
Version Model Number | SA39W |
Company DUNS | 551471161 |
Company Name | Shenzhen Teslong Technology Co.,Ltd |
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 | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Device Issuing Agency | Device ID |
---|---|
GS1 | 06973919590075 [Primary] |
ERA | Otoscope |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-07-07 |
Device Publish Date | 2023-06-29 |
06973919590105 | MS500 |
06973919590099 | MS450-NTE |
06973919590082 | MS430 |
06973919590075 | SA39W |
06973919590068 | SA39A |
06973919590051 | NTE100I |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OTOSCOPE 77875618 3905524 Live/Registered |
Smith, Richard J.H. 2009-11-18 |