ENDOGATOR Hybrid Irrigation Tubing

GUDID 00677964060106

MEDIVATORS INC.

Surgical irrigation tubing set, single-use
Primary Device ID00677964060106
NIH Device Record Key6fbe6bf2-37f3-46b6-b520-0895207b40fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameENDOGATOR Hybrid Irrigation Tubing
Version Model Number100630
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100677964060106 [Primary]
GS110677964060103 [Package]
Package: Carton [10 Units]
In Commercial Distribution
GS120677964060100 [Package]
Package: Case [30 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 Number5
Public Version Date2019-04-23
Device Publish Date2016-09-22

On-Brand Devices [ENDOGATOR Hybrid Irrigation Tubing]

00677964081989100606B
00677964081972100605B
00677964060861100608
20677964060858100606
00677964060830100605
00677964060113100631
00677964060106100630
00677964052361100610
00677964052354100609

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