Primary Device ID | 00810032660819 |
NIH Device Record Key | 3436261d-c8fb-485e-a0d3-06ebddaeb469 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Isolite, i3 |
Version Model Number | PIL0307 |
Catalog Number | PIL0307 |
Company DUNS | 068038277 |
Company Name | ZYRIS, INC. |
Device Count | 1 |
DM Exempt | true |
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 | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Phone | +1(800)560-6066 |
regulatory@zyris.com | |
Phone | +1(800)560-6066 |
regulatory@zyris.com | |
Phone | +1(800)560-6066 |
regulatory@zyris.com | |
Phone | +1(800)560-6066 |
regulatory@zyris.com | |
Phone | +1(800)560-6066 |
regulatory@zyris.com | |
Phone | +1(800)560-6066 |
regulatory@zyris.com | |
Phone | +1(800)560-6066 |
regulatory@zyris.com | |
Phone | +1(800)560-6066 |
regulatory@zyris.com | |
Phone | +1(800)560-6066 |
regulatory@zyris.com | |
Phone | +1(800)560-6066 |
regulatory@zyris.com | |
Phone | +1(800)560-6066 |
regulatory@zyris.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810032660819 [Primary] |
EAZ | LIGHT, OPERATING, DENTAL |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810032660819]
Moist Heat or Steam Sterilization
[00810032660819]
Moist Heat or Steam Sterilization
[00810032660819]
Moist Heat or Steam Sterilization
[00810032660819]
Moist Heat or Steam Sterilization
[00810032660819]
Moist Heat or Steam Sterilization
[00810032660819]
Moist Heat or Steam Sterilization
[00810032660819]
Moist Heat or Steam Sterilization
[00810032660819]
Moist Heat or Steam Sterilization
[00810032660819]
Moist Heat or Steam Sterilization
[00810032660819]
Moist Heat or Steam Sterilization
[00810032660819]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-04-29 |
Device Publish Date | 2024-04-19 |
00810032660963 | Isolite Pro ~ Isolite 3, Anterior Adapter Kit |
00810032660956 | Vacuum Light Pipe, Si, i3 |
00810032660949 | 0.25 BSP Spiral Fitting |
00810032660932 | Power Vacuum Base, OUS, i3 |
00810032660925 | Power Adaptor, AUS, 4.5m, i3 |
00810032660901 | Power Adaptor, EU, 4.5m, i3 |
00810032660888 | Accessory Kit, Dentsply Sirona |
00810032660871 | Sirona Suction Port, Teneo |
00810032660864 | Sirona Suction Port, Intego |
00810032660857 | Power Cable Extension Cord, 30cm |
00810032660840 | Adaptor, Power, 12VDC-1Amp, 15ft, i3 |
00810032660833 | Cleaning Tip, Re-circulation, i3 |
00810032660826 | Barb Fitting, 10.5mm, i3 |
00810032660819 | Cleaning Tip, i3 |
00810032660802 | Vacuum Lever Set, i3 |
00810032660796 | Power Terminal Cable, i3 |
00810032660789 | Adaptor, Power, 12VDC-1Amp, i3 |
00810032660772 | Power Vacuum Base, i3 |
00810032660765 | Control Head Hose, i3 |