ORBIT GALAXY XTRASOFT

Basic Information

• Brand Name: ORBIT GALAXY XTRASOFT
• Primary DI: 10886704030737
• Version / Model: 640HX0208
• Catalog Number: 640HX0208
• Company Name: Medos International Sàrl
• Labeler DUNS: 482661753
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-20
• Public Version: 7
• Public Version Date: 2021-12-22
• Public Version Status: Update
• Public Device Record Key: d1036810-f695-4ac8-b432-8d8eb5f7262d

Device Description

ORBIT GALAXY Detachable Coil System 175cm 2mm 8cm Contents: 1 detachable coil Systemand 1 luer valve. Coil Type: Healical Xtrasoft Note: ONLY use with TRUFILL DCS Syringe II

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KRD	Device, Vascular, for Promoting Embolization	Cardiovascular	870.3300	2
HCG	DEVICE, NEUROVASCULAR EMBOLIZATION	Neurology	882.5950	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17846	Vascular guide-catheter, single-use	A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10886704030737	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K093973	000