Rist™

GUDID 00763000413804

CATH RADIAL DX 105F-BER-130 V01 US

Micro Therapeutics, Inc.

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 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: 00763000413804
• NIH Device Record Key: 57166d22-0df5-45b5-831c-9fa90a1cedf5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rist™
• Version Model Number: 105F-BER-130
• Company DUNS: 826110710
• Company Name: Micro Therapeutics, Inc.
• 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: false
• 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)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Store the product in its original packaging, including the outer shelf carton, in a clean, cool, and dry area to protect the product and minimize the potential for contamination.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000413804 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200417

FDA Product Code

• DQY: Catheter, percutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-12-22
• Device Publish Date: 2020-10-05

On-Brand Devices [Rist™]

• 00763000413828: CATH RADIAL DX 105F-SIM-130 V01 US
• 00763000413811: CATH RADIAL DX 105F-SIM-120 V01 US
• 00763000413804: CATH RADIAL DX 105F-BER-130 V01 US
• 00763000413798: CATH RADIAL DX 105F-BER-120 V01 US
• 00763000413781: SHEATH RADIAL LONG 107F-079-105 V01 US
• 00763000413774: SHEATH RADIAL LONG 107F-079-100 V01 US
• 00763000413767: SHEATH RADIAL LONG 107F-079-95 V01 US