Axonpen

GUDID 00860000321303

Axonpen Endoscope

Clearmind Biomedical Inc.

Surgical irrigation/aspiration cannula, illuminating, single-use
Primary Device ID00860000321303
NIH Device Record Key9bf4bc14-4894-4553-8188-8536e2d6016a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAxonpen
Version Model NumberAH-50-110
Company DUNS658832644
Company NameClearmind Biomedical 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 Usetrue
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
GS100860000321303 [Primary]
GS110860000321300 [Package]
Package: Carton [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWGEndoscope, Neurological

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-16
Device Publish Date2022-02-08

Devices Manufactured by Clearmind Biomedical Inc.

10860000321317 - Axonpen System2022-02-28 Axonbox
00860000321341 - ClearPath2022-02-28 ClearPath Disposable Introducer
00860000321303 - Axonpen2022-02-16Axonpen Endoscope
00860000321303 - Axonpen2022-02-16 Axonpen Endoscope

Trademark Results [Axonpen]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AXONPEN
AXONPEN
90450916 not registered Live/Pending
Clearmind Biomedical, Inc.
2021-01-06

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