Apollo Balloon Dilatation Catheter 802-2220U

GUDID 06958481454079

BrosMed Medical Co.,Ltd.

Coronary angioplasty balloon catheter, basic
Primary Device ID06958481454079
NIH Device Record Key46a4f080-5030-468f-a920-deb34fa2c182
Commercial Distribution StatusIn Commercial Distribution
Brand NameApollo Balloon Dilatation Catheter
Version Model Numberrev 02
Catalog Number802-2220U
Company DUNS421318800
Company NameBrosMed Medical Co.,Ltd.
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106958481454079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-07
Device Publish Date2016-09-26

On-Brand Devices [Apollo Balloon Dilatation Catheter]

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