ORBIT GALAXY XTRASOFT 640CX0406

GUDID 10886704030621

ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=4mm 6cm Contents: 1 detachable coil system and 1 luer valve. Coil Type: Complex Xtrasoft

Medos International Sàrl

Vascular guide-catheter, single-use

• Primary Device ID: 10886704030621
• NIH Device Record Key: a9a641b4-cd0b-4402-8da6-0bc1e82925e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORBIT GALAXY XTRASOFT
• Version Model Number: 640CX0406
• Catalog Number: 640CX0406
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• 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
• 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	10886704030621 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093973

FDA Product Code

• KRD: Device, Vascular, for Promoting Embolization

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-09-20

On-Brand Devices [ORBIT GALAXY XTRASOFT]

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• 10886704030713: ORBIT GALAXY Detachable Coil System 175cm 2mm 4cm Contents: 1 detachable coil system and 1 luer
• 10886704030706: ORBIT GALAXY Detachable Coil System 175cm 3.5mm 7.5cm Contents: 1 detachable coil system and 1 l
• 10886704030690: ORBIT GALAXY Detachable Coil System 175cm 3.5mm 9cm Contents: 1 detachable coil system and 1 lue
• 10886704030683: ORBIT GALAXY Detachable Coil System 175cm 3.5mm 5cm Contents: 1 detachable coil system and 1 lue
• 10886704030676: ORBIT GALAXY Detachable Coil System 175cm 2.5mm 3.5cm Contents: 1 detachable coil system and 1 l
• 10886704030669: ORBIT GALAXY Detachable Coil System 175cm 2.5mm 2.5cm Contents: 1 detachable coil system and 1 l
• 10886704030652: ORBIT GALAXY Detachable Coil System 175cm 2.5mm 5cm Contents: 1 detachable coil system and 1 lue
• 10886704030645: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=4mm 10cm Co
• 10886704030638: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=4mm 8cm Con
• 10886704030621: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=4mm 6cm Con
• 10886704030614: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=4mm 4cm Con
• 10886704030607: ORBIT GALAXY Detachable Coil System 175cm 3mm 8cm Contents: 1 detachable coil system and 1 luer
• 10886704030591: ORBIT GALAXY Detachable Coil System 175cm 3mm 6cm Contents: 1 detachable coil system and 1 luer
• 10886704030584: ORBIT GALAXY Detachable Coil System 175cm 3mm 4cm Contents: 1 detachable coil system and 1 luer
• 10886704030577: ORBIT GALAXY Detachable Coil System 175cm 3mm 3cm Contents: 1 detachable coil system and 1 luer
• 10886704030546: ORBIT GALAXY Detachable Coil System 175cm 2mm 2cm Contents: 1 detachable coil system and 1 luer
• 10886704030539: ORBIT GALAXY Detachable Coil System 175cm 2mm 1.5cm Contents: 1 detachable coil system and 1 lue