Intra.Ox Disposable Sheath OXY-2-STH-1

GUDID B426OXY2STH10

VIOPTIX, INC.

Tissue saturation oximeter sensor, single-use
Primary Device IDB426OXY2STH10
NIH Device Record Keye3a5997d-6909-4d00-abf6-4f502eb43225
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntra.Ox Disposable Sheath
Version Model NumberOXY2-STH-1
Catalog NumberOXY-2-STH-1
Company DUNS127211923
Company NameVIOPTIX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
HIBCCB426OXY2STH10 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUDOximeter, Tissue Saturation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-27
Device Publish Date2020-04-17

Devices Manufactured by VIOPTIX, INC.

B426OXY2DUR10 - Intra.Ox Smart Sensor2020-04-27
B426OXY2QCT10 - Intra.Ox Optical QC Target2020-04-27
B426OXY2STH10 - Intra.Ox Disposable Sheath2020-04-27
B426OXY2STH10 - Intra.Ox Disposable Sheath2020-04-27
B426OXY2SPD10 - T.Ox SP Sensor2018-07-06
B426OXY2SPI10 - T.Ox SS Sensor2018-07-06

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