AccessGUDID - DEVICE: i-ED COIL (04540778177079)

GUDID

Device Identifier (DI) Information

Brand Name: i-ED COIL
Version or Model: 392-0515
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 392-0515
Company Name: KANEKA CORPORATION

Primary DI Number: 04540778177079
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690535406 *Terms of Use

Device Description: The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60941	Non-neurovascular embolization coil	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.	Active	true
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HCG	Device, Neurovascular Embolization
KRD	Device, Vascular, For Promoting Embolization

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in a clean and cool place avoiding getting wet and direct sunlight, extreme temperature, or high humidity.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Complex (Soft) 12inch 5mm x 15cm
Device Size Text, specify: Compatible Microcatheter inner diameter: 0.42 to 0.48 Millimeter

Device Record Status

Public Device Record Key: 34e7dc07-bad5-413e-a15a-4df849e42cd0
Public Version Date: September 11, 2023
Public Version Number: 4
DI Record Publish Date: June 30, 2020