Staysite Adhesive

GUDID 07640121880568

The Staysite Adhesive (SA-MAR), is an optional, single-use adhesive which is indicated for use with Multi-Site Attachment Rings, models MAR-MI and MAR

SenTec AG

Transcutaneous blood gas monitoring system
Primary Device ID07640121880568
NIH Device Record Key6cad696c-2261-416e-a80b-6ea996415130
Commercial Distribution StatusIn Commercial Distribution
Brand NameStaysite Adhesive
Version Model NumberSA-MAR
Company DUNS480797856
Company NameSenTec AG
Device Count1
DM Exempttrue
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
GS107640121880568 [Primary]
GS117640121880565 [Package]
Package: Box [50 Units]
In Commercial Distribution
GS127640121880562 [Package]
Package: Box [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DPZOximeter, Ear

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-31

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