AccessGUDID - DEVICE: PROWLER SELECT (10886704028864)

GUDID

Device Identifier (DI) Information

Brand Name: PROWLER SELECT
Version or Model: 606-S255JX
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 606S255JX
Company Name: Medos International Sàrl

Primary DI Number: 10886704028864
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 482661753 *Terms of Use

Device Description: PROWLER SELECT PLUS TIP MARKERS 2 TIPSHAPE J Infusion Catheter 2.8F (0.95mm) 2.3F (0.75mm) .021 Inch (0.5mm) 5cm 150cm Contents: 1 Infusion Catheter and 1 Shape Mandrel. Minimum Guiding Catheter I.D. / Dia. .042 Inch (1.1mm)

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
KRA	Catheter, continuous flush

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K021591	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
Special Storage Condition, Specify: STORE IN A COOL, DARK, DRY PLACE

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dd9b080f-75ea-424c-ab35-2204d3c6155f
Public Version Date: January 29, 2020
Public Version Number: 5
DI Record Publish Date: June 30, 2016