Primary Device ID | 05708265012305 |
NIH Device Record Key | 2b175dae-901e-4046-96d6-1118950a10e5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | LiNA OperåScope™ Needle 4mm |
Version Model Number | OP-NEE4-6 |
Company DUNS | 305088619 |
Company Name | Lina Medical ApS |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +48612222149 |
info.poland@lina-medical.com | |
Phone | +48612222149 |
info.poland@lina-medical.com | |
Phone | +48612222149 |
info.poland@lina-medical.com | |
Phone | +48612222149 |
info.poland@lina-medical.com | |
Phone | +48612222149 |
info.poland@lina-medical.com | |
Phone | +48612222149 |
info.poland@lina-medical.com | |
Phone | +48612222149 |
info.poland@lina-medical.com | |
Phone | +48612222149 |
info.poland@lina-medical.com | |
Phone | +48612222149 |
info.poland@lina-medical.com | |
Phone | +48612222149 |
info.poland@lina-medical.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05708265012299 [Primary] |
GS1 | 05708265012305 [Package] Contains: 05708265012299 Package: [6 Units] In Commercial Distribution |
FBK | Endoscopic Injection Needle, Gastroenterology-Urology |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-10-11 |
Device Publish Date | 2022-10-03 |
05708265013326 - LiNA Xcise™, Laparoscopic Morcellator | 2024-10-02 15mm battery powered morcellator system with obturator |
05708265013340 - LiNA Xcise™, Laparoscopic Morcellator | 2024-10-01 15mm battery powered morcellator system with obturator |
05708265013944 - LiNA CystoVu™ HD | 2024-10-01 LiNA CystoVu™ HD, Single-use Flexible Cystoscope, Standard Deflection |
05708265013975 - LiNA CystoVu™ HD | 2024-10-01 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 Lasso | 2024-09-27 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 - EpiGuard | 2023-06-15 Epi-Guard - Achoring device for epidural catheters |