LiNA OperåScope™ Recording Module OP‐RM‐1

GUDID 05708265010233

Lina Medical ApS

Medical video image recorder Medical video image recorder Medical video image recorder Medical video image recorder Medical video image recorder Medical video image recorder Medical video image recorder Medical video image recorder Medical video image recorder Medical video image recorder Medical video image recorder Medical video image recorder Medical video image recorder Medical video image recorder Medical video image recorder Medical video image recorder Medical video image recorder Medical video image recorder Medical video image recorder Medical video image recorder Medical video image recorder Medical video image recorder Medical video image recorder Medical video image recorder Medical video image recorder Medical video image recorder Medical video image recorder Medical video image recorder
Primary Device ID05708265010233
NIH Device Record Key8c5490fe-0b22-42c3-b4c5-2a13a6798ec0
Commercial Distribution StatusIn Commercial Distribution
Brand NameLiNA OperåScope™ Recording Module
Version Model NumberOP‐RM‐1
Catalog NumberOP‐RM‐1
Company DUNS305088619
Company NameLina Medical ApS
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 Usefalse
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

Customer Support Contacts

Phone+48 612222149
Emailinfo.poland@lina-medical.com
Phone+48 612222149
Emailinfo.poland@lina-medical.com
Phone+48 612222149
Emailinfo.poland@lina-medical.com
Phone+48 612222149
Emailinfo.poland@lina-medical.com
Phone+48 612222149
Emailinfo.poland@lina-medical.com
Phone+48 612222149
Emailinfo.poland@lina-medical.com
Phone+48 612222149
Emailinfo.poland@lina-medical.com
Phone+48 612222149
Emailinfo.poland@lina-medical.com
Phone+48 612222149
Emailinfo.poland@lina-medical.com
Phone+48 612222149
Emailinfo.poland@lina-medical.com
Phone+48 612222149
Emailinfo.poland@lina-medical.com
Phone+48 612222149
Emailinfo.poland@lina-medical.com
Phone+48 612222149
Emailinfo.poland@lina-medical.com
Phone+48 612222149
Emailinfo.poland@lina-medical.com
Phone+48 612222149
Emailinfo.poland@lina-medical.com
Phone+48 612222149
Emailinfo.poland@lina-medical.com
Phone+48 612222149
Emailinfo.poland@lina-medical.com
Phone+48 612222149
Emailinfo.poland@lina-medical.com
Phone+48 612222149
Emailinfo.poland@lina-medical.com
Phone+48 612222149
Emailinfo.poland@lina-medical.com
Phone+48 612222149
Emailinfo.poland@lina-medical.com
Phone+48 612222149
Emailinfo.poland@lina-medical.com
Phone+48 612222149
Emailinfo.poland@lina-medical.com
Phone+48 612222149
Emailinfo.poland@lina-medical.com
Phone+48 612222149
Emailinfo.poland@lina-medical.com
Phone+48 612222149
Emailinfo.poland@lina-medical.com
Phone+48 612222149
Emailinfo.poland@lina-medical.com
Phone+48 612222149
Emailinfo.poland@lina-medical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105708265010233 [Primary]

FDA Product Code

HIHHysteroscope (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-06-07
Device Publish Date2018-02-21

On-Brand Devices [LiNA OperåScope™ Recording Module]

05708265010233OP‐RM‐1
05708265013449OP-RM-1

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