Zyris, Isovac EIV0102

GUDID 00810032660307

Isovac, Three Pack

ZYRIS, INC.

Dental suction system
Primary Device ID00810032660307
NIH Device Record Key14fb080c-2521-4f6a-84b9-fd601b9a6414
Commercial Distribution StatusIn Commercial Distribution
Brand NameZyris, Isovac
Version Model NumberEIV0102
Catalog NumberEIV0102
Company DUNS068038277
Company NameZYRIS, INC.
Device Count3
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
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
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
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100810032660307 [Primary]
GS110810032660304 [Unit of Use]

FDA Product Code

EBRUNIT, SUCTION OPERATORY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


[00810032660307]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-02
Device Publish Date2019-09-24

On-Brand Devices [Zyris, Isovac]

00810032660314Isovac, EDU, 2-Pack, UCLA
00810032660307Isovac, Three Pack
00810032660291Isovac, Single

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