N/A IC71132UG

GUDID 10886704082378

Large Bore Catheter 0.085 in (2.16 mm) Minimum Guide Diameter Proximal OD: 0.0825 in / 2.10 mm Distal OD: 0.0810 in / 2.06 mm ID: 0.071 in / 1.80 mm Working length: 132 cm

Medos International Sàrl

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use

• Primary Device ID: 10886704082378
• NIH Device Record Key: 6b248fee-e501-4ae9-94e3-763296192e44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: IC71132UG
• Catalog Number: IC71132UG
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• Device Count: 1
• DM Exempt: true
• 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: false
• 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: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886704082378 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191237

FDA Product Code

• DQY: Catheter, percutaneous

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: 2019-12-10
• Device Publish Date: 2019-12-02

On-Brand Devices [N/A]

• 10886704082385: Large Bore Catheter 0.085 in (2.16 mm) Minimum Guide Diameter Proximal OD: 0.0825 in / 2.10 mm D
• 10886704082378: Large Bore Catheter 0.085 in (2.16 mm) Minimum Guide Diameter Proximal OD: 0.0825 in / 2.10 mm D
• 10886704082361: Large Bore Catheter 0.085 in (2.16 mm) Minimum Guide Diameter Proximal OD: 0.0825 in / 2.10 mm D
• 10705034558158: UNIVERSAL NAVIGATION ADAPTOR SET NAVIGATION RING diameter 12 - ST
• 10705034536224: UNIVERSAL NAVIGATION ADAPTOR SET NAVIGATION ARRAY ORANGE 3 SPHERES
• 10705034536217: UNIVERSAL NAVIGATION ADAPTOR SET NAVIGATION ARRAY VIOLET 4 SPHERES
• 10705034536200: UNIVERSAL NAVIGATION ADAPTOR SET NAVIGATION ARRAY GREY 3 SPHERES
• 10705034536194: UNIVERSAL NAVIGATION ADAPTOR SET NAVIGATION ARRAY YELLOW 3 SPHERES
• 10705034536187: UNIVERSAL NAVIGATION ADAPTOR SET NAVIGATION ARRAY BLUE 3 SPHERES
• 10705034536156: UNIVERSAL NAVIGATION ADAPTOR SET NAVIGATION RING diameter 12
• 10705034536170: UNIVERSAL NAVIGATION ADAPTOR SET NAVIGATION RING diameter 22
• 10705034536163: UNIVERSAL NAVIGATION ADAPTOR SET NAVIGATION RING diameter 17