Soft SR Detachable Coil
GDC-10 - M003341201SR40
Device Description
A non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an aneurysm or the vasculature surrounding a malformation; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.
Environmental Conditions
- Store in cool, dry, dark place.
Device Sizes
- Coil Length: 1.0 Centimeter
- Secondary Coil Diameter: 2.0 Millimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: HCG
Device Name: Device, Neurovascular Embolization
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: NE
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: N/A
Regulation Number: 882.5950
Third Party Flag: N
Medical Specialty: NE
Device IdentifiersDevice Id: 07613252188759
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A