Isolite, i2 PIL0204

GUDID 00810032660703

Vacuum Light Pipe

ZYRIS, INC.

Dental suction system
Primary Device ID00810032660703
NIH Device Record Key4a25d7b6-eb69-4a33-aa05-81f1ccd4993e
Commercial Distribution StatusIn Commercial Distribution
Brand NameIsolite, i2
Version Model NumberPIL0204
Catalog NumberPIL0204
Company DUNS068038277
Company NameZYRIS, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(800)560-6066
Emailregulatory@zyris.com
Phone+1(800)560-6066
Emailregulatory@zyris.com
Phone+1(800)560-6066
Emailregulatory@zyris.com
Phone+1(800)560-6066
Emailregulatory@zyris.com
Phone+1(800)560-6066
Emailregulatory@zyris.com
Phone+1(800)560-6066
Emailregulatory@zyris.com
Phone+1(800)560-6066
Emailregulatory@zyris.com
Phone+1(800)560-6066
Emailregulatory@zyris.com
Phone+1(800)560-6066
Emailregulatory@zyris.com
Phone+1(800)560-6066
Emailregulatory@zyris.com
Phone+1(800)560-6066
Emailregulatory@zyris.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810032660703 [Primary]

FDA Product Code

EAZLIGHT, OPERATING, DENTAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810032660703]

Moist Heat or Steam Sterilization


[00810032660703]

Moist Heat or Steam Sterilization


[00810032660703]

Moist Heat or Steam Sterilization


[00810032660703]

Moist Heat or Steam Sterilization


[00810032660703]

Moist Heat or Steam Sterilization


[00810032660703]

Moist Heat or Steam Sterilization


[00810032660703]

Moist Heat or Steam Sterilization


[00810032660703]

Moist Heat or Steam Sterilization


[00810032660703]

Moist Heat or Steam Sterilization


[00810032660703]

Moist Heat or Steam Sterilization


[00810032660703]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-29
Device Publish Date2024-04-19

On-Brand Devices [Isolite, i2]

00810032660758Isolite 2 ; Isodry Anterior Adapter Kit
00810032660734Power Adaptor, 5VDC-1Amp, Grey
00810032660710Vacuum Lever Set
00810032660703Vacuum Light Pipe

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