TYSHAK II® 611920

GUDID 04046964339011

PDC520 16MM X 4CM BALL CATH TYSHA II STD

B BRAUN INTERVENTIONAL SYSTEMS, INC

Cardiac valvuloplasty catheter
Primary Device ID04046964339011
NIH Device Record Keycf14b09b-9950-4fb9-95d5-29f4f73baea3
Commercial Distribution StatusIn Commercial Distribution
Brand NameTYSHAK II®
Version Model Number611920
Catalog Number611920
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
GS104046964339011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LITCatheter, angioplasty, peripheral, transluminal

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 II®]

04046964339615PDC550 TYSHAK II 30 X 6 SP
04046964339592PDC549 TYSHAK II 30 X 5 SP
04046964339578PDC548 TYSHAK II 30 X 4 SP
04046964339554PDC547 TYSHAK II 30 X 3 SP
04046964339530PDC546 25MM X 6CM BALL CATH TYSHA II STD
04046964339516PDC545 25MM X 5CM BALL CATH TYSHA II STD
04046964339493PDC544 25MM X 4CM BALL CATH TYSHA II STD
04046964339479PDC543 TYSHAK II 25 X 3 SP
04046964339455PDC542 TYSHAK II 23 X 6 SP
04046964339431PDC541 23MM X 5CM BALL CATH TYSHA II STD
04046964339417PDC540 23MM X 4CM BALL CATH TYSHA II STD
04046964339394PDC539 TYSHAK II 23 X 3 SP
04046964339370PDC538 22MM X 6CM BALL CATH TYSHA II STD
04046964339356PDC537 22MM X 5CM BALL CATH TYSHA II STD
04046964339332PDC536 22MM X 4CM BALL CATH TYSHA II STD
04046964339318PDC535 TYSHAK II 22 X 3 SP
04046964339295PDC534 20MM X 6CM BALL CATH TYSHA II STD
04046964339271PDC533 20MM X 5CM BALL CATH TYSHA II STD
04046964339257PDC532 20MM X 4CM BALL CATH TYSHA II STD
04046964339233PDC531 20MM X 3CM BALL CATH TYSHA II STD
04046964339219PDC530 18MM X 6CM BALL CATH TYSHA II STD
04046964339202PDC529 18MM X 5CM BALL CATH TYSHA II STD
04046964339172PDC528 TYSHAK II 18 X 4 STD
04046964339158PDC527 18MM X 3CM BALL CATH TYSHA II STD
04046964339141PDC526 TYSHAK II 17 X 6 SP
04046964339127PDC525 TYSHAK II 17 X 5 SP
04046964339097PDC524 TYSHAK II 17 X 4 SP
04046964339080PDC523 TYSHAK II 17 X 3 SP
04046964339059PDC522 TYSHAK II 16 X 6 SP
04046964339035PDC521 16MM X 5CM BALL CATH TYSHA II STD
04046964339011PDC520 16MM X 4CM BALL CATH TYSHA II STD
04046964339004PDC519 TYSHAK II 16 X 3 STD
04046964338953PDC517 15MM X 5CM BALL CATH TYSHA II STD
04046964338946PDC516 15MM X 4CM BALL CATH TYSHA II STD
04046964338922PDC515 15MM X 3CM BALL CATH TYSHA II STD
04046964338908PDC514 TYSHAK II 14 X 6 SP
04046964338885PDC513 TYSHAK II 14 X 5 SP
04046964338861PDC512 TYSHAK II 14 X 4 STD
04046964338847PDC511 TYSHAK II 14 X 3 STD
04046964338823SO008 12MM X 2CM BALL CATH TYSHAK II STD
04046964338809SO003 10MM X 2CM BALL CATH TYSHAK II STD
04046964338786SO007 TYSHAK II 9MM 2CM STD
04046964338205SO038 TYSHAK II 17MM 8CM
04046964338182SO037 TYSHAK II 16MM 8CM SP
04046964338168SO036 TYSHAK II 13MM 3CM SP
04046964338144SO035 TYSHAK II 13MM 2CM SP
04046964338120SO034 TYSHAK II 13MM 4CM SP
04046964338106SO033 TYSHAK II 12MM 5CM SP
04046964338083SO032 TYSHAK II 8MM 5CM SP
04046964338069SO031 Z-MED TYSHAK II 10MM 5CM

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