V8 V8-1924

GUDID 00859945004112

V8 Balloon Aortic Valvuloplasty Catheter, V8-1924

INTERVALVE INC

Cardiac valvuloplasty catheter
Primary Device ID00859945004112
NIH Device Record Key2e265b6c-e000-43f5-a325-1d510db2f779
Commercial Distribution Discontinuation2018-09-08
Commercial Distribution StatusNot in Commercial Distribution
Brand NameV8
Version Model NumberV8-1924
Catalog NumberV8-1924
Company DUNS037375827
Company NameINTERVALVE INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6123969849
Emailspetrie@libramed.com

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100859945004112 [Primary]

FDA Product Code

OZTBalloon Aortic Valvuloplasty

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-09-10
Device Publish Date2016-09-08

On-Brand Devices [V8]

00859945004174V8 Balloon Aortic Valvuloplasty Catheter, TAV8-2328
00859945004167V8 Balloon Aortic Valvuloplasty Catheter, TAV8-2126
00859945004150V8 Balloon Aortic Valvuloplasty Catheter, TAV8-1924
00859945004143V8 Balloon Aortic Valvuloplasty Catheter, TAV8-1722
00859945004136V8 Balloon Aortic Valvuloplasty Catheter, V8-2328
00859945004129V8 Balloon Aortic Valvuloplasty Catheter, V8-2126
00859945004112V8 Balloon Aortic Valvuloplasty Catheter, V8-1924
00859945004105V8 Balloon Aortic Valvuloplasty Catheter, V8-1722
00859945004099V8 Balloon Aortic Valvuloplasty Catheter, 232812C110
00859945004082V8 Balloon Aortic Valvuloplasty Catheter, 212612C110
00859945004075V8 Balloon Aortic Valvuloplasty Catheter, 192412C110
00859945004068V8 Balloon Aortic Valvuloplasty Catheter, 172212C110

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