LiNA OperaScope™ Tubing & Drape kit OP-TDK-6

GUDID 05708265011186

Tubing & drape for hysteroscopy

Lina Medical ApS

Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use

• Primary Device ID: 05708265011186
• NIH Device Record Key: 46caac41-f338-42ad-9c96-4c0d26487d18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LiNA OperaScope™ Tubing & Drape kit
• Version Model Number: OP-TDK-6
• Catalog Number: OP-TDK-6
• 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

Customer Support Contacts

• Phone: +48 612222149
• Email: info.poland@lina-medical.com
• Phone: +48 612222149
• Email: info.poland@lina-medical.com
• Phone: +48 612222149
• Email: info.poland@lina-medical.com
• Phone: +48 612222149
• Email: info.poland@lina-medical.com
• Phone: +48 612222149
• Email: info.poland@lina-medical.com
• Phone: +48 612222149
• Email: info.poland@lina-medical.com
• Phone: +48 612222149
• Email: info.poland@lina-medical.com
• Phone: +48 612222149
• Email: info.poland@lina-medical.com
• Phone: +48 612222149
• Email: info.poland@lina-medical.com
• Phone: +48 612222149
• Email: info.poland@lina-medical.com
• Phone: +48 612222149
• Email: info.poland@lina-medical.com
• Phone: +48 612222149
• Email: info.poland@lina-medical.com
• Phone: +48 612222149
• Email: info.poland@lina-medical.com
• Phone: +48 612222149
• Email: info.poland@lina-medical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05708265011179 [Primary]
GS1	05708265011186 [Package]; Contains: 05708265011179; Package: box [6 Units]; In Commercial Distribution

FDA Product Code

• NVT: Tubing And Tubing/Filter Fits

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: 2020-08-11
• Device Publish Date: 2020-08-03

On-Brand Devices [LiNA OperaScope™ Tubing & Drape kit]

• 05708265010592: Tubing & drape for hysteroscopy
• 05708265011858: Tubing & drape for hysteroscopy
• 05708265011186: Tubing & drape for hysteroscopy
• 05708265012480: Tubing & drape Kit intended for hysteroscopy and cystoscopy