NuCLEUS-X™ 612036

GUDID 04046964340277

PVN416 NUCLEUS X BALLOON 30X5X110 W6

B BRAUN INTERVENTIONAL SYSTEMS, INC

Cardiac valvuloplasty catheter
Primary Device ID04046964340277
NIH Device Record Keyb174b979-16af-499a-aa56-d7f954744d36
Commercial Distribution StatusIn Commercial Distribution
Brand NameNuCLEUS-X™
Version Model Number612036
Catalog Number612036
Company DUNS784259751
Company NameB BRAUN INTERVENTIONAL SYSTEMS, 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

Phone+1(877)836-2228
Email[email protected]

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *ROOM TEMP AWAY FROM SUNLIGHT

Device Identifiers

Device Issuing AgencyDevice ID
GS104046964340277 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQYCATHETER, PERCUTANEOUS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-03-25
Device Publish Date2016-09-21

On-Brand Devices [NuCLEUS-X™]

04046964340345PVN410 NUCLEUS X BALLOON 25X5X110 W6
04046964340321PVN402 NUCLEUS X BALLOON 18X6X110 W5
04046964340307PVN400 NUCLEUS X BALLOON 18X4X110 W5
04046964340291PVN417 NUCLEUS X BALLOON 30X6X110 W6
04046964340277PVN416 NUCLEUS X BALLOON 30X5X110 W6
04046964340246PVN415 NUCLEUS X BALLOON 30X4X110 W6
04046964340222PVN414 NUCLEUS X BALLOON 28X6X110 W6
04046964340208PVN413 NUCLEUS X BALLOON 28X5X110 W6
04046964340185PVN412 NUCLEUS X BALLOON 28X4X110 W6
04046964340161PVN411 NUCLEUS X BALLOON 25X6X110 W6
04046964340147PVN409 NUCLEUS X BALLOON 25X4X110 W6
04046964340123PVN408 NUCLEUS X BALLOON 22X6X110 W6
04046964340109PVN407 NUCLEUS X BALLOON 22X5X110 W6
04046964340086PVN406 NUCLEUS X BALLOON 22X4X110 W6
04046964340062PVN405 NUCLEUS X BALLOON 20X6X110 W5
04046964340048PVN404 NUCLEUS X BALLOON 20X5X110 W5
04046964340024PVN403 NUCLEUS X BALLOON 20X4X110 W5
04046964340000PVN401 NUCLEUS X BALLOON 18X5X110 W5

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