Primary Device ID | 00192896071759 |
NIH Device Record Key | 62407566-d157-4cdf-ae25-ec7237ab0acd |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OMEGA 500 LED MODULE |
Version Model Number | X-008.87.200 |
Catalog Number | X-008.87.200 |
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 | 00192896071759 [Primary] |
FSP | LOUPE, DIAGNOSTIC/SURGICAL |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00192896071759]
Dry Heat Sterilization;Moist Heat or Steam 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 |
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