Primary Device ID | DO3686200011 |
NIH Device Record Key | b9bc0f61-1925-478d-9fd8-dd44f33cfb16 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | RIVA CONDITIONER |
Version Model Number | RIVA CONDITIONER 10ML PK |
Catalog Number | 8620001 |
Company DUNS | 753221852 |
Company Name | SDI LIMITED |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +18002285166 |
info@sdi.com.au |
Handling Environment Atmospheric Pressure | Between 10 Degrees Celsius and 25 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | DO3686200011 [Primary] |
EBC | SEALANT, PIT AND FISSURE, AND CONDITIONER |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-30 |
DO3684520041 - LUNA 2 | 2024-02-16 |
DO3684520251 - LUNA 2 | 2024-02-16 |
DO3686400011 - STELA | 2024-02-16 |
DO3686400021 - STELA | 2024-02-16 |
DO3686400031 - STELA | 2024-02-16 |
DO3686400041 - STELA | 2024-02-16 |
DO3686400061 - STELA | 2024-02-16 |
DO3685600011 - AURA | 2019-12-16 |