Navigation Patient Patches MBR-000016

GUDID B634MBR0000161

Navigation Patient Patches (Quantity of 60)

AURIS HEALTH, INC.

Hypoallergenic skin adhesive tape Hypoallergenic skin adhesive tape
Primary Device IDB634MBR0000161
NIH Device Record Keyf2ee1f2a-f1b5-4c65-b07d-f45ff01f4cd4
Commercial Distribution StatusIn Commercial Distribution
Brand NameNavigation Patient Patches
Version Model NumberMBR-000016
Catalog NumberMBR-000016
Company DUNS015823456
Company NameAURIS HEALTH, 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
HIBCCB634MBR0000160 [Primary]
HIBCCB634MBR0000161 [Package]
Contains: B634MBR0000160
Package: Box [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOQBronchoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-10-23
Device Publish Date2018-06-08

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