andorate® Irrigation Tubing

GUDID 14897106955043

GA Health Company Limited

Surgical irrigation tubing set, single-use
Primary Device ID14897106955043
NIH Device Record Keyfaf39c5d-bfef-4f04-8e09-fd9a4106b4d4
Commercial Distribution StatusIn Commercial Distribution
Brand Nameandorate® Irrigation Tubing
Version Model NumberGAR083
Company DUNS686908512
Company NameGA Health Company Limited
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
GS104897106955046 [Primary]
GS114897106955043 [Package]
Contains: 04897106955046
Package: Box [10 Units]
In Commercial Distribution
GS124897106955040 [Package]
Package: Carton [4 Units]
In Commercial Distribution

FDA Product Code

OCXEndoscopic Irrigation/Suction System

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-08
Device Publish Date2022-01-31

Devices Manufactured by GA Health Company Limited

04897106957040 - andorate® Port Brush2024-08-15
14897106955784 - andorate® Air Water Channel Cleaning Adapter + 3-piece Valve Kit2023-10-12
14897106955791 - andorate® Air Water Channel Cleaning Adapter + 3-piece Valve Kit2023-10-12
14897106955807 - andorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit2023-10-12
14897106955814 - andorate® Air Water Channel Cleaning Adapter + 3-piece Valve Kit2023-10-12
14897106955821 - andorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit2023-10-12
14897106955838 - andorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit2023-10-12
14897106955869 - andorate® CO2 Source Tubing Adapter2023-09-07

Trademark Results [andorate]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ANDORATE
ANDORATE
97445913 not registered Live/Pending
GA HEALTH COMPANY LIMITED
2022-06-07
ANDORATE
ANDORATE
97445874 not registered Live/Pending
GA HEALTH COMPANY LIMITED
2022-06-07
ANDORATE
ANDORATE
87709057 5589076 Live/Registered
GA HEALTH COMPANY LIMITED
2017-12-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.