LiNA OperåScope™ Needle 8mm

GUDID 05708265012343

LiNA OperåScope™ Needle 8mm, minimum channel diameter: Ø 2mm

Lina Medical ApS

General-purpose endoscopic needle, single-use
Primary Device ID05708265012343
NIH Device Record Key9c3ef390-df2e-4d4d-ae6d-0de3ea9e5fc6
Commercial Distribution StatusIn Commercial Distribution
Brand NameLiNA OperåScope™ Needle 8mm
Version Model NumberOP-NEE8-6
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 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+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
GS105708265012336 [Primary]
GS105708265012343 [Package]
Contains: 05708265012336
Package: [6 Units]
In Commercial Distribution

FDA Product Code

FBKEndoscopic Injection Needle, Gastroenterology-Urology

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-11
Device Publish Date2022-10-03

Devices Manufactured by Lina Medical ApS

05708265013326 - LiNA Xcise™, Laparoscopic Morcellator2024-10-02 15mm battery powered morcellator system with obturator
05708265013340 - LiNA Xcise™, Laparoscopic Morcellator2024-10-01 15mm battery powered morcellator system with obturator
05708265013944 - LiNA CystoVu™ HD2024-10-01 LiNA CystoVu™ HD, Single-use Flexible Cystoscope, Standard Deflection
05708265013975 - LiNA CystoVu™ HD2024-10-01 LiNA CystoVu™ HD, Single-use Flexible Cystoscope , Reverse Deflection
05708265014002 - LiNA ScopeVu™ 2024-10-01 LiNA ScopeVu™ Full HD display and light source
05708265011537 - LiNA OperaScopeTM Lasso2024-09-27 LiNA OperaScopeTM Lasso is intended for use in hysteroscopy procedures.
05708265011520 - LiNA OperaScope™ Lasso 2024-09-25 The LiNA OperaScopeTM Lasso is intended for use in hysteroscopy procedures.
05708265000036 - EpiGuard2023-06-15 Epi-Guard - Achoring device for epidural catheters

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.