Stop'n GO Double Balloon Catheter

GUDID 04250203940870

Joline GmbH & Co. KG

Inflatable bone tamp
Primary Device ID04250203940870
NIH Device Record Key93b5ab6b-6e58-417c-b08d-e3fe9da6d944
Commercial Distribution StatusIn Commercial Distribution
Brand NameStop'n GO Double Balloon Catheter
Version Model NumberUS9420
Company DUNS342087108
Company NameJoline GmbH & Co. KG
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104250203940870 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXArthroscope

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-24
Device Publish Date2020-08-14