SLT IVUS Support Crossing Catheter P018150

GUDID 00850045446024

Intravascular ultrasound imaging catheter, single-use

Primary Device ID	00850045446024
NIH Device Record Key	9a1c95e9-9e70-4cd0-bf41-043c21034c61
Commercial Distribution Status	In Commercial Distribution
Brand Name	SLT IVUS Support Crossing Catheter
Version Model Number	P018150
Catalog Number	P018150
Company DUNS	015877254
Company Name	Provisio Medical, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00850045446024 [Primary]

OJB	Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate

Steralize Prior To Use	false
Device Is Sterile	true

00850045446000 - SLT IVUS P1 Pulser Receiver Unit	2024-06-03 See LBL-0998, SLT IVUS P1 System Manual
00850045446024 - SLT IVUS Support Crossing Catheter	2024-06-03The 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.
00850045446024 - SLT IVUS Support Crossing Catheter	2024-06-03 The SLT IVUS Support Crossing Catheters are over-the-wire intravascular ultrasound catheters with a digital ultrasound transduce
00850045446031 - SLT IVUS P1 Display Unit	2024-06-03 See LBL-0998, SLT IVUS P1 System Manual
00850045446048 - SLT IVUS P1 Cart	2024-06-03 See LBL-0998, SLT IVUS P1 System Manual