Accessory Kit

GUDID 00850048825055

Galaxy system accessory kit

Noah Medical Corporation

Flexible video bronchoscope, reusable
Primary Device ID00850048825055
NIH Device Record Keyc16272b9-d1b8-4da0-a225-b9078713388e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccessory Kit
Version Model Number10000799
Company DUNS117566482
Company NameNoah Medical Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850048825055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOQBronchoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00850048825055]

Ethylene Oxide


[00850048825055]

Ethylene Oxide


[00850048825055]

Ethylene Oxide


[00850048825055]

Ethylene Oxide


[00850048825055]

Ethylene Oxide


[00850048825055]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-23
Device Publish Date2024-12-15

Devices Manufactured by Noah Medical Corporation

00850048825055 - Accessory Kit2024-12-23Galaxy system accessory kit
00850048825055 - Accessory Kit2024-12-23 Galaxy system accessory kit
00850048825062 - Basic Accessory Kit2024-12-23 Galaxy system basic accessory kit
00850048825000 - Bronchoscope2024-12-19 The Galaxy System and bronchoscopic is intended to provide visualization of patient airways for diagnostic procedures.
00850048825017 - Bronchoscope connector2024-12-19 Bronchoscope connector
00850048825031 - Bronchoscope guide2024-12-19 Scope guide
00000850048825 - Galaxy System2024-11-19 The Galaxy System is designed with the intent to enable articulation and precise control of a flexible, single-use disposable br

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