EpiGuard

GUDID 05708265000036

Epi-Guard - Achoring device for epidural catheters

Lina Medical ApS

Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder

• 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 Identifiers

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

FDA Product Code

• KGZ: Accessories, Catheter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-15
• Device Publish Date: 2023-06-07

Devices Manufactured by Lina Medical ApS

• 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