Primary Device ID | 05708265000036 |
NIH Device Record Key | 89850a53-b534-4590-b0f4-eb0af9508053 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | EpiGuard |
Version Model Number | 8170 |
Company DUNS | 305088619 |
Company Name | Lina Medical ApS |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05708265000036 [Package] Contains: 05708265000241 Package: box [25 Units] In Commercial Distribution |
GS1 | 05708265000241 [Primary] |
GS1 | 05708265008865 [Package] Package: box [4 Units] In Commercial Distribution |
KGZ | Accessories, Catheter |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-06-15 |
Device Publish Date | 2023-06-07 |
05708265000036 - EpiGuard | 2023-06-15Epi-Guard - Achoring device for epidural catheters |
05708265000036 - EpiGuard | 2023-06-15 Epi-Guard - Achoring device for epidural catheters |
05708265000012 - Drain Guard | 2023-06-15 Drain-Guard - Achoring device for percutaneous drainage catheters. |
05708265001088 - LiNA PowerBlade™ | 2023-06-15 LiNA PowerBlade, Bipolar cutting & coagulation forceps, curved jaws, Ø 5,4mm, 185 mm working length, 3m cable, EURO connector |
05708265004430 - LiNA PowerBlade™ | 2023-06-15 LiNA PowerBlade, Bipolar cutting & coagulation forceps, straight jaws, Ø 10mm, 330 mm working length, 3m cable, EURO connector |
05708265004454 - LiNA PowerBlade™ | 2023-06-15 LiNA PowerBlade, Bipolar cutting & coagulation forceps, curved jaws, Ø 5,4mm, 330 mm working length, 3m cable, EURO connector |
05708265004737 - LiNA PowerBlade Plus™ | 2023-06-15 LiNA PowerBlade Plus – 5mm endoscopic bipolar coagulation and cutting forceps. Length: 330mm. 3m cable and fixed 2-pin 4mm mal |
05708265005703 - Pleura-Guard | 2023-06-15 Pleura-Guard - Anchoring device for thoracic drainage catheters from 16-30 french. |
05708265005932 - LiNA PowerBlade™ | 2023-06-15 LiNA PowerBlade, Bipolar cutting & coagulation forceps, straight jaws, Ø 10mm, 330 mm working length, 3m cable, EURO connector |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
EPIGUARD 88864323 not registered Live/Pending |
EPIGUARD AS 2020-04-08 |
EPIGUARD 79121451 4437961 Live/Registered |
LayTec Aktiengesellschaft 2012-09-14 |