AccessGUDID - DEVICE: Neuroform Stabilizer (07613252193951)

GUDID

Device Identifier (DI) Information

Brand Name: Neuroform Stabilizer
Version or Model: M003SNF3STA0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M003SNF3STA0
Company Name: Stryker Corporation

Primary DI Number: 07613252193951
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042405446 *Terms of Use

Device Description: 2F Stabilizer Catheter

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):	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?
10691	Vascular microcatheter	A sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NJE	intracranial neurovascular stent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
H020002	000
H020002	003
H020002	005
H020002	009
H020002	011
H020002	012
H020002	031
H020002	035
H020002	047
H020002	053
H020002	054

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 cool, dry, dark place.

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 0.016 Inch
Length: 152.0 Centimeter

Device Record Status

Public Device Record Key: 8173372f-172b-444d-ac2c-e461848c291b
Public Version Date: August 27, 2020
Public Version Number: 7
DI Record Publish Date: May 02, 2016