Anterior Hose Kit PIL0330

GUDID 00810032661007

Isolite Core, Hose Kit

ZYRIS, INC.

Dental suction system
Primary Device ID00810032661007
NIH Device Record Key6af98d07-daad-49d3-96b4-d84981cb1ca7
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnterior Hose Kit
Version Model NumberPIL0330
Catalog NumberPIL0330
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
GS100810032661007 [Primary]

FDA Product Code

EBRUNIT, SUCTION OPERATORY

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

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

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00810032660703 - Isolite, i22024-04-29 Vacuum Light Pipe
00810032660710 - Isolite, i22024-04-29 Vacuum Lever Set
00810032660734 - Isolite, i22024-04-29 Power Adaptor, 5VDC-1Amp, Grey
00810032660758 - Isolite, i22024-04-29 Isolite 2 ; Isodry Anterior Adapter Kit
00810032660765 - Isolite, i32024-04-29 Control Head Hose, i3

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