TYSHAK NuCLEUS™ 612112

GUDID 04046964511936

TN035 TYSHAK NUCLEUS 22X4X100

B BRAUN INTERVENTIONAL SYSTEMS, INC

Cardiac valvuloplasty catheter
Primary Device ID04046964511936
NIH Device Record Key21d8b050-73c1-4175-93d2-3d2f6f7eec80
Commercial Distribution StatusIn Commercial Distribution
Brand NameTYSHAK NuCLEUS™
Version Model Number612112
Catalog Number612112
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 *KEEP DRY

Device Identifiers

Device Issuing AgencyDevice ID
GS104046964511936 [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 Date2016-08-09

On-Brand Devices [TYSHAK NuCLEUS™]

04046964511950TN037 TYSHAK NUCLEUS 25X4X100
04046964511943TN036 TYSHAK NUCLEUS 25X3X100
04046964511936TN035 TYSHAK NUCLEUS 22X4X100
04046964511929TN034 TYSHAK NUCLEUS 22X3X100
04046964511912TN033 TYSHAK NUCLEUS 20X4X100
04046964511905TN032 TYSHAK NUCLEUS 20X3X100
04046964511899TN031 TYSHAK NUCLEUS 18X4X100
04046964511882TN030 TYSHAK NUCLEUS 18X3X100
04046964511875TN029 TYSHAK NUCLEUS 16X4X100
04046964511868TN028 TYSHAK NUCLEUS 16X3X100
04046964511851TN027 TYSHAK NUCLEUS 15X4X100
04046964511844TN026 TYSHAK NUCLEUS 15X3X100
04046964511837TN025 TYSHAK NUCLEUS 14X4X100
04046964511820TN024 TYSHAK NUCLEUS 14X3X100
04046964511813TN023 TYSHAK NUCLEUS 12X4X100
04046964511806TN022 TYSHAK NUCLEUS 12X3X100
04046964511790TN021 TYSHAK NUCLEUS 12X2X100
04046964511783TN020 TYSHAK NUCLEUS 10X4X100
04046964511776TN019 TYSHAK NUCLEUS 10X3X100
04046964511769TN018 TYSHAK NUCLEUS 10X2X100
04046964511752TN017 TYSHAK NUCLEUS 9X4X100
04046964511745TN016 TYSHAK NUCLEUS 9X3X100
04046964511738TN015 TYSHAK NUCLEUS 9X2X100
04046964511721TN014 TYSHAK NUCLEUS 8X4X100
04046964511714TN013 TYSHAK NUCLEUS 8X3X100
04046964511707TN012 TYSHAK NUCLEUS 8X2X100
04046964511691TN011 TYSHAK NUCLEUS 7X4X100
04046964511684TN010 TYSHAK NUCLEUS 7X3X100
04046964511677TN009 TYSHAK NUCLEUS 7X2X100
04046964511660TN008 TYSHAK NUCLEUS 6X4X100
04046964511653TN007 TYSHAK NUCLEUS 6X3X100
04046964511646TN006 TYSHAK NUCLEUS 6X2X100
04046964511639TN005 TYSHAK NUCLEUS 5X4X100
04046964511622TN004 TYSHAK NUCLEUS 5X3X100
04046964511615TN003 TYSHAK NUCLEUS 5X2X100
04046964511608TN002 TYSHAK NUCLEUS 4X3X100
04046964511493TN001 TYSHAK NUCLEUS 4X2X100

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