Pentax Irrigation Tubing

GUDID 20677964060360

MEDIVATORS INC.

Surgical irrigation tubing set, single-use
Primary Device ID20677964060360
NIH Device Record Key4eedb737-eb1f-4bfe-bb0c-92f4ca8ecdfc
Commercial Distribution StatusIn Commercial Distribution
Brand NamePentax Irrigation Tubing
Version Model Number100125P
Company DUNS068199363
Company NameMEDIVATORS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com
Phone+1(800)444-4729
Emailcustserv@MEDIVATORS.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100677964060366 [Primary]
GS110677964060363 [Package]
Contains: 00677964060366
Package: Carton [10 Units]
In Commercial Distribution
GS120677964060360 [Package]
Contains: 00677964060366
Package: Case [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OCXEndoscopic Irrigation/Suction System

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-04-23
Device Publish Date2018-08-15

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