ORBIT GALAXY 640CF0202

GUDID 10886704030195

ORBIT GALAXY Detachable Coil System Complex Fill 2cm 2mm 175cm Contents: 1 detachable coil system and 1 luer valve. Coil Type: Complex Fill

Medos International Sàrl

Vascular guide-catheter, single-use

• Primary Device ID: 10886704030195
• NIH Device Record Key: b4c6e65f-8d62-4221-81fe-abff67eab400
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORBIT GALAXY
• Version Model Number: 640CF0202
• Catalog Number: 640CF0202
• 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
• 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
• 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	10886704030195 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093973

FDA Product Code

• HCG: DEVICE, NEUROVASCULAR 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]

• 10886704030522: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=20mm 30cm C
• 10886704030515: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=18mm 30cm C
• 10886704030508: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=16mm 30cm C
• 10886704030492: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=14mm 30cm C
• 10886704030485: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=12mm 30cm C
• 10886704030478: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=10mm 30cm C
• 10886704030461: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=9mm 30cm Co
• 10886704030454: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=8mm 30cm Co
• 10886704030447: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=7mm 25cm Co
• 10886704030430: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=6mm 20cm Co
• 10886704030423: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=12mm 30cm C
• 10886704030416: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=10mm 30cm C
• 10886704030409: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=9mm 25cm Co
• 10886704030393: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=9mm 15cm Co
• 10886704030386: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=8mm 24cm Co
• 10886704030379: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=8mm 15cm Co
• 10886704030362: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=7mm 21cm Co
• 10886704030355: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=7mm 15cm Co
• 10886704030348: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=6mm 20cm Co
• 10886704030331: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=6mm 15cm Co
• 10886704030324: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=6mm 10cm Co
• 10886704030300: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=5mm 15cm Co
• 10886704030294: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=5mm 10cm Co
• 10886704030287: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=5mm 5cm Con
• 10886704030270: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=4mm 12cm Co
• 10886704030263: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=4mm 10cm Co
• 10886704030256: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=4mm 7cm Con
• 10886704030249: ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=4mm 4cm Con
• 10886704030225: ORBIT GALAXY Detachable Coil System Complex Fill 8cm 3mm 175cm Contents: 1 detachable coil syste
• 10886704030218: ORBIT GALAXY Detachable Coil System Complex Fill 6cm 3mm 175cm Contents: 1 detachable coil syste
• 10886704030201: ORBIT GALAXY Detachable Coil System Complex Fill 4cm 3mm 175cm Contents: 1 detachable coil syste
• 10886704030195: ORBIT GALAXY Detachable Coil System Complex Fill 2cm 2mm 175cm Contents: 1 detachable coil syste
• 10886704030188: ORBIT GALAXY Detachable Coil System Complex Fill 1.5cm 2mm 175cm Contents: 1 detachable coil sys