M-CATH Flexy 820135732

GUDID 07640132622690

Microcatheter

Acrostak (Schweiz) AG

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: 07640132622690
• NIH Device Record Key: 313ea34e-52cf-40f6-8877-65c0c9187a92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M-CATH Flexy
• Version Model Number: 820135732
• Catalog Number: 820135732
• Company DUNS: 484613497
• Company Name: Acrostak (Schweiz) AG
• 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: 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: +41522339551
• Email: clinical@acrostak.com
• Phone: +41522339551
• Email: clinical@acrostak.com
• Phone: +41522339551
• Email: clinical@acrostak.com
• Phone: +41522339551
• Email: clinical@acrostak.com
• Phone: +41522339551
• Email: clinical@acrostak.com
• Phone: +41522339551
• Email: clinical@acrostak.com
• Phone: +41522339551
• Email: clinical@acrostak.com
• Phone: +41522339551
• Email: clinical@acrostak.com
• Phone: +41522339551
• Email: clinical@acrostak.com
• Phone: +41522339551
• Email: clinical@acrostak.com
• Phone: +41522339551
• Email: clinical@acrostak.com
• Phone: +41522339551
• Email: clinical@acrostak.com
• Phone: +41522339551
• Email: clinical@acrostak.com
• Phone: +41522339551
• Email: clinical@acrostak.com
• Phone: +41522339551
• Email: clinical@acrostak.com
• Phone: +41522339551
• Email: clinical@acrostak.com
• Phone: +41522339551
• Email: clinical@acrostak.com
• Phone: +41522339551
• Email: clinical@acrostak.com
• Phone: +41522339551
• Email: clinical@acrostak.com
• Phone: +41522339551
• Email: clinical@acrostak.com
• Phone: +41522339551
• Email: clinical@acrostak.com
• Phone: +41522339551
• Email: clinical@acrostak.com
• Phone: +41522339551
• Email: clinical@acrostak.com
• Phone: +41522339551
• Email: clinical@acrostak.com
• Phone: +41522339551
• Email: clinical@acrostak.com
• Phone: +41522339551
• Email: clinical@acrostak.com
• Phone: +41522339551
• Email: clinical@acrostak.com
• Phone: +41522339551
• Email: clinical@acrostak.com
• Phone: +41522339551
• Email: clinical@acrostak.com

Device Dimensions

• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter
• Length: 135 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640132622690 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171176

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: 2021-11-09
• Device Publish Date: 2021-11-01

On-Brand Devices [M-CATH Flexy ]

• 07640132622706: Microcatheter
• 07640132622690: Microcatheter