MICRUSPHERE

Basic Information

• Brand Name: MICRUSPHERE
• Primary DI: 00878528003809
• Version / Model: SPH181200-20
• Catalog Number: SPH18120020
• Company Name: Medos International Sàrl
• Labeler DUNS: 482661753
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-20
• Public Version: 5
• Public Version Date: 2023-11-29
• Public Version Status: Update
• Public Device Record Key: 4f737bc8-09d0-46e3-99c2-d17b104f7063
• Distribution End Date: 2019-12-30

Device Description

MICRUSPHERE microcoil MICRUSPHERE 18 Platinum Coil 12mm x 20.7cm 190cm Contents: 1 Detachable Coil System

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
60940	Neurovascular embolization coil	A non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00878528003809	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K142429	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry
• Type: Handling Environment Temperature
• Temperature Range: 0 – 45 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 32 – 110 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 0 – 45 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 32 – 110 Degrees Fahrenheit