N/A

GUDID 00847536003873

ED2-RM-US DETACHMENT SYSTEM

Reverse Medical Corporation

Vascular implant detacher, reusable

• Primary Device ID: 00847536003873
• NIH Device Record Key: c943f47f-dfab-4522-9acb-318d96933cfe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: ED2-RM-US
• Company DUNS: 963324913
• Company Name: Reverse Medical Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry, secure place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry, secure place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry, secure place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry, secure place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry, secure place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry, secure place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry, secure place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry, secure place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry, secure place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry, secure place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry, secure place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry, secure place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry, secure place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry, secure place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a clean, dry, secure place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847536003873 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123803

FDA Product Code

• KRD: Device, Vascular, for Promoting Embolization

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-08-08
• Device Publish Date: 2015-10-23

On-Brand Devices [N/A]

• 00847536003873: ED2-RM-US DETACHMENT SYSTEM
• 00847536003835: RMCS-2.75US DETACHMENT CABLE SET