AccessGUDID - DEVICE: Comaneci 17 (07290015107150)

GUDID

Device Identifier (DI) Information

Brand Name: Comaneci 17
Version or Model: ANPP7199
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: RAPID MEDICAL LTD

Primary DI Number: 07290015107150
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 532702946 *Terms of Use

Device Description: The Comaneci is intended for use in the neurovasculature to assist in the coil embolization of wide-necked intracranial aneurysms under fluoroscopic guidance. The Comaneci is comprised of a collapsible, fully retrievable, fine wire construction mounted on a wire shaft that expands to comply with the vessel diameter. It is delivered through a neurovascular microcatheter. The Comaneci is provided with a 3.5 French (F) peelable loading sheath.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46352	Bare-metal intracranial vascular stent	A non-bioabsorbable tubular device typically intended to be implanted into the base or parent artery of an intracranial aneurysm (e.g., wide-neck aneurysm situated at the base of a bifurcation) to facilitate the delivery of embolics to fill the aneurysm, facilitate clotting within the aneurysm by slowing blood flow into it, and/or to provide support for a neurovascular embolization coil placed inside the aneurysm. It is made of uncoated metal [e.g., nickel-titanium alloy (Nitinol)] and self-expands after it is delivered to the site of implantation and released (e.g., from a dedicated delivery instrument). Disposable devices associated with implantation may be included.	Active	true

FDA Product Code

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Product Code	Product Code Name
PUU	Temporary Coil Embolization Assist Device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN170064	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 74d854b1-8ef5-487c-ac3c-886ba1801898
Public Version Date: February 05, 2021
Public Version Number: 3
DI Record Publish Date: May 17, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number	Quantity per Package	Contains DI Package	Package Status
27290015107154	4	17290015107157	In Commercial Distribution
17290015107157	3	07290015107150	In Commercial Distribution
37290015107151	2	07290015107150	In Commercial Distribution