Smart Kit SpeedTrack Stop'n GO 2 x 8 mm

GUDID 04250203940504

Joline GmbH & Co. KG

Balloon kyphoplasty kit
Primary Device ID04250203940504
NIH Device Record Keyee9d71cc-a55e-4302-8bcd-88228b34578e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmart Kit SpeedTrack Stop'n GO 2 x 8 mm
Version Model NumberUS7NS2200
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 Kittrue
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
GS104250203940504 [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