AccessGUDID - DEVICE: NumenFR (06958698011690)

GUDID

Device Identifier (DI) Information

Brand Name: NumenFR
Version or Model: E101
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MicroPort NeuroTech (Shanghai) Co., Ltd.

Primary DI Number: 06958698011690
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 551973856 *Terms of Use

Device Description: The MicroPort NeuroTech NumenFR Detachment System is a sterile, handheld, single-patient use device designed for use with MicroPort NeuroTech Numen Coil Embolization System. The device is operated by two pre-loaded batteries.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
60637	Vascular implant detacher, electronic, single-use	A noninvasive, hand-held, electrically-powered unit intended to deliver a low-level electric current to break the connection between a vascular implantable device (typically a neurovascular or peripheral embolization coil or stent) and its deployment device (i.e., implant inserter or delivery wire) via an electrolytic reaction. It is intended to connect to the proximal end of an appropriate implant inserter (delivery wire) which conducts the current to the electrically-unstable detachment point. This is a single-use device.	Active	false

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 [?]
K203625	000
K232955	000
K242154	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: 7043dae5-2760-4475-9fd3-f193582fcd45
Public Version Date: November 05, 2024
Public Version Number: 5
DI Record Publish Date: March 15, 2022