TYSHAK X™ 618312

GUDID 04046964313325

TYSHAK-X 10X4X6X6X100X.035 PDC312

B BRAUN INTERVENTIONAL SYSTEMS, INC

Cardiac valvuloplasty catheter
Primary Device ID04046964313325
NIH Device Record Key6cc4eff7-7002-4a7b-b6b8-58e7939e4fd9
Commercial Distribution StatusIn Commercial Distribution
Brand NameTYSHAK X™
Version Model Number618312
Catalog Number618312
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
GS104046964313325 [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 X™]

04046964314032TYSHAK-X 25X6X11X9X100X.035 PDC347
04046964314018TYSHAK-X 25X5X11X9X100X.035 PDC346
04046964313998TYSHAK-X 25X4X11X9X100X.035 PDC345
04046964313974TYSHAK-X 25X3X11X9X100X.035 PDC344
04046964313950TYSHAK-X 22X6X10X9X100X.035 PDC343
04046964313936TYSHAK-X 22X5X10X9X100X.035 PDC342
04046964313912TYSHAK-X 22X4X10X9X100X.035 PDC341
04046964313899TYSHAK-X 22X3X10X9X100X.035 PDC340
04046964313875TYSHAK-X 20X6X10X8X100X.035 PDC339
04046964313851TYSHAK-X 20X5X10X8X100X.035 PDC338
04046964313837TYSHAK-X 20X4X10X8X100X.035 PDC337
04046964313813TYSHAK-X 20X3X10X8X100X.035 PDC336
04046964313790TYSHAK-X 18X6X9X8X100X.035 PDC335
04046964313776TYSHAK-X 18X5X9X8X100X.035 PDC334
04046964313752TYSHAK-X 18X4X9X8X100X.035 PDC333
04046964313721TYSHAK-X 18X3X9X8X100X.035 PDC332
04046964313707TYSHAK-X 16X6X8X7X100X.035 PDC331
04046964313684TYSHAK-X 16X5X8X7X100X.035 PDC330
04046964313660TYSHAK-X 16X4X8X7X100X.035 PDC329
04046964313646TYSHAK-X 16X3X8X7X100X.035 PDC328
04046964313622TYSHAK-X 15X6X8X7X100X.035 PDC327
04046964313608TYSHAK-X 15X5X8X7X100X.035 PDC326
04046964313585TYSHAK-X 15X4X8X7X100X.035 PDC325
04046964313561TYSHAK-X 15X3X8X7X100X.035 PDC324
04046964313547TYSHAK-X 14X6X8X7X100X.035 PDC323
04046964313523TYSHAK-X 14X5X8X7X100X.035 PDC322
04046964313509TYSHAK-X 14X4X8X7X100X.035 PDC321
04046964313486TYSHAK-X 14X3X8X7X100X.035 PDC320
04046964313462TYSHAK-X 12X6X7X6X100X.035 PDC319
04046964313448TYSHAK-X 12X5X7X6X100X.035 PDC318
04046964313424TYSHAK-X 12X4X7X6X100X.035 PDC317
04046964313400TYSHAK-X 12X3X7X6X100X.035 PDC316
04046964313387TYSHAK-X 12X2X7X6X100X.035 PDC315
04046964313363TYSHAK-X 10X6X6X6X100X.035 PDC314
04046964313349TYSHAK-X 10X5X6X6X100X.035 PDC313
04046964313325TYSHAK-X 10X4X6X6X100X.035 PDC312
04046964313301TYSHAK-X 10X3X6X6X100X.035 PDC311
04046964313288TYSHAK-X 10X2X6X6X100X.035 PDC310
04046964313264TYSHAK-X 9X6X6X6X100X.035 PDC309
04046964313240TYSHAK-X 9X5X6X6X100X.035 PDC308
04046964313226TYSHAK-X 9X4X6X6X100X.035 PDC307
04046964313202TYSHAK-X 9X3X6X6X100X.035 PDC306
04046964313189TYSHAK-X 9X2X6X6X100X.035 PDC305
04046964313158TYSHAK-X 8X6X6X6X100X.035 PDC304
04046964313134TYSHAK-X 8X5X6X6X100X.035 PDC303
04046964313127TYSHAK-X 8X4X6X6X100X.035 PDC302
04046964313097TYSHAK-X 8X3X6X6X100X.035 PDC301
04046964313073TYSHAK-X 8X2X6X6X100X.035 PDC300

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