AccessGUDID - DEVICE: SLT IVUS Support Crossing Catheter (00850045446024)

GUDID

Device Identifier (DI) Information

Brand Name: SLT IVUS Support Crossing Catheter
Version or Model: P018150
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P018150
Company Name: Provisio Medical, Inc.

Primary DI Number: 00850045446024
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015877254 *Terms of Use

Device Description: The SLT IVUS Support Crossing Catheters are over-the-wire intravascular ultrasound catheters with a digital ultrasound transducer array at the distal end that also functions as support crossing catheter.

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":	Yes
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?
44141	Intravascular ultrasound imaging catheter, single-use	A flexible, non-steerable tube with an ultrasound imaging transducer enclosed in a fluid-resistant or waterproof acoustically- and electrically-insulated housing, designed for insertion into the vascular system (i.e., peripheral vascular system, coronary artery) by an operator; it is not intended for intracardial insertion/imaging. Also known as a vascular ultrasound transducer, it includes either a single or an array of transducer element(s) (piezoelectric, active, or crystal); it cannot be manoeuvred via controls (i.e., non-steerable). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OJB	Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate
DQY	Catheter, Percutaneous
ITX	Transducer, Ultrasonic, Diagnostic
IYO	System, Imaging, Pulsed Echo, Ultrasonic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K233948	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: 9a1c95e9-9e70-4cd0-bf41-043c21034c61
Public Version Date: June 03, 2024
Public Version Number: 1
DI Record Publish Date: May 24, 2024