TYSHAK Mini® 611985

GUDID 04046964339639

PDC400 TYSHAK MINI 4MM 2CM

B BRAUN INTERVENTIONAL SYSTEMS, INC

Cardiac valvuloplasty catheter
Primary Device ID04046964339639
NIH Device Record Key05928407-a8a7-4bbc-ae58-2de793712061
Commercial Distribution StatusIn Commercial Distribution
Brand NameTYSHAK Mini®
Version Model Number611985
Catalog Number611985
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
GS104046964339639 [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 Mini®]

04046964339981SO101 TYSHAK MINI 7MM, 1CM, 3F
04046964339950SO104 TYSHAK MINI 10MM, 1CM, 4F
04046964339936SO103 TYSHAK MINI 9MM, 1CM, 4F
04046964339912SO102 TYSHAK MINI 8MM, 1CM, 3F
04046964339851SO098 TYSHAK MINI 6MM, 1CM, 3 FR
04046964339837SO097 TYSHAK MINI 5MM, 1CM, 3FR
04046964339813SO095 TYSHAK MINI 4MM, 1 CM, 3 FR
04046964339790PDC408 TYSHAK MINI 10MM 4CM
04046964339776PDC407 TYSHAK MINI 9MM 4CM
04046964339752PDC406 TYSHAK MINI 10MM 2CM
04046964339738PDC405 TYSHAK MINI 9MM 2CM
04046964339714PDC404 TYSHAK MINI 8MM 2CM
04046964339691PDC403 TYSHAK MINI 7MM 2CM
04046964339677PDC402 TYSHAK MINI 6MM 2CM
04046964339653PDC401 TYSHAK MINI 5MM 2CM
04046964339639PDC400 TYSHAK MINI 4MM 2CM

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