Primary Device ID | 00843511100698 |
NIH Device Record Key | 983186b9-15a3-435b-afcc-0d4d01c6a378 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Omnia Medical Disc Prep |
Version Model Number | 16-6P-SUC1 |
Catalog Number | 16-6P-SUC1 |
Company DUNS | 079467378 |
Company Name | OMNIA MEDICAL, LLC |
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 | 3044134851 |
customerservice@omniamedical.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00843511100698 [Primary] |
JOL | Catheter And Tip, Suction |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00843511100698]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-01-28 |
Device Publish Date | 2020-01-20 |
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00843511102081 - Omnia Medical TiBrid™-C | 2024-03-22 CONVEX RASP, 09mm |
00843511102098 - Omnia Medical TiBrid™-C | 2024-03-22 CONVEX RASP, 10mm |