LiNA OperaScopeTM Lasso OP-LAS16-3

GUDID 05708265011537

LiNA OperaScopeTM Lasso is intended for use in hysteroscopy procedures.

Lina Medical ApS

Mechanical-cutting endoscopic polypectomy snare
Primary Device ID05708265011537
NIH Device Record Keye83e94fd-bbfe-40cc-931d-3385897075d6
Commercial Distribution Discontinuation2019-09-26
Commercial Distribution StatusNot in Commercial Distribution
Brand NameLiNA OperaScopeTM Lasso
Version Model NumberOP-LAS16-3
Catalog NumberOP-LAS16-3
Company DUNS305088619
Company NameLina Medical ApS
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 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+48612222149
Emailinfo.poland@lina-medical.com
Phone+48612222149
Emailinfo.poland@lina-medical.com
Phone+48612222149
Emailinfo.poland@lina-medical.com
Phone+48612222149
Emailinfo.poland@lina-medical.com
Phone+48612222149
Emailinfo.poland@lina-medical.com
Phone+48612222149
Emailinfo.poland@lina-medical.com
Phone+48612222149
Emailinfo.poland@lina-medical.com
Phone+48612222149
Emailinfo.poland@lina-medical.com
Phone+48612222149
Emailinfo.poland@lina-medical.com
Phone+48612222149
Emailinfo.poland@lina-medical.com
Phone+48612222149
Emailinfo.poland@lina-medical.com
Phone+48612222149
Emailinfo.poland@lina-medical.com
Phone+48612222149
Emailinfo.poland@lina-medical.com
Phone+48612222149
Emailinfo.poland@lina-medical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105708265011537 [Primary]
GS105708265011544 [Package]
Package: [3 Units]
Discontinued: 2019-09-26
Not in Commercial Distribution

FDA Product Code

GAESnare, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-09-27
Device Publish Date2019-08-26

On-Brand Devices [LiNA OperaScopeTM Lasso]

05708265011896LiNA OperaScopeTM Lasso is intended for use in hysteroscopy procedures.
05708265011537LiNA OperaScopeTM Lasso is intended for use in hysteroscopy procedures.

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.