GALAXY G3 · GLY120308
Cerenovus, Inc. · GALAXY G3 Microcoil 12 Stretch Resistant Coil and Detachable Coil System Contents: 1 Detachable Coil System Coil Type:…
Open FDA's page for this record- Has donation ID number
- false
- Mri safety
- MR Conditional
- Record status
- Published
- Is labeled as nrl
- false
- Is rx
- true
- Commercial distribution status
- In Commercial Distribution
- Public device record key
- d2d42e27-16f3-4d23-92e0-57145e19876c
- Has serial number
- false
- Public version date
- 2026-08-03
- Is direct marking exempt
- false
- Public version number
- 6
- Labeler duns number
- 607846297
- Is labeled as no nrl
- false
- Is single use
- true
- Is otc
- false
- Version or model number
- GLY120308
- Has manufacturing date
- false
- Brand name
- GALAXY G3
- Is combination product
- false
- Is kit
- false
- Device count in base package
- 1
- Is pm exempt
- false
- Has lot or batch number
- true
- Catalog number
- GLY120308
- Company name
- Cerenovus, Inc.
- Public version status
- Update
- Has expiration date
- true
- Is hct p
- false
- Publish date
- 2016-11-16
- Device description
GALAXY G3 Microcoil 12 Stretch Resistant Coil and Detachable Coil System Contents: 1 Detachable Coil System Coil Type: GALAXY G3 12 Stretch Resistant Coil 3mm (coil diameter) x 8cm (coil length) 190cm (working length)
- Sterilization
- Is sterile
- true
- Is sterilization prior use
- false
- Identifiers
- ID
- 10886704077466
- Type
- Primary
- Issuing agency
- GS1
- Product codes
- Code
- KRD
- Name
- Device, Vascular, for Promoting Embolization
- Harmonized identifiers (openFDA)
- Device name
- Device, Vascular, For Promoting Embolization
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.3300
- Device class
- 2
- Code
- HCG
- Name
- DEVICE, NEUROVASCULAR EMBOLIZATION
- Harmonized identifiers (openFDA)
- Device name
- Device, Neurovascular Embolization
- Medical specialty description
- Neurology
- Regulation number
- 882.5950
- Device class
- 2
- Customer contacts
- Phone
- +1(800)255-2500
- xx@xx.xx
- Gmdn terms
- Code
- 60940
- Name
- Neurovascular embolization coil
- Implantable
- true
- Code status
- Active
- Definition
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.