FLEX Vessel Prep System FSC 4-75

GUDID 00863656000325

Coronary angioplasty balloon catheter, cutting/scoring

Primary Device ID	00863656000325
NIH Device Record Key	1c32e000-db71-407a-a57e-1595acc01418
Commercial Distribution Status	In Commercial Distribution
Brand Name	FLEX Vessel Prep System
Version Model Number	FSC 4-75
Catalog Number	FSC 4-75
Company DUNS	027796091
Company Name	VENTUREMED GROUP, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00863656000325 [Primary]

PNO	Catheter, Percutaneous, Cutting/Scoring

Steralize Prior To Use	false
Device Is Sterile	true

00863656000325 - FLEX Vessel Prep System	2023-04-11FLEX Vessel Prep System, FSC 4-75
00863656000325 - FLEX Vessel Prep System	2023-04-11 FLEX Vessel Prep System, FSC 4-75
00863656000301 - FLEX	2019-07-05 FLEX Vessel Prep System Long Basket
00863656000318 - FLEX AV	2019-07-05 FLEX Vessel Prep system for arteriovenous fistulae