Reprocessed VAPR Cool Pulse Electrode, Hand Contro

GUDID B3902281471

SURETEK MEDICAL

Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed
Primary Device IDB3902281471
NIH Device Record Key0f5c567e-0de3-40df-bbed-0804cdd41231
Commercial Distribution StatusIn Commercial Distribution
Brand NameReprocessed VAPR Cool Pulse Electrode, Hand Contro
Version Model Number228147
Company DUNS785616934
Company NameSURETEK MEDICAL
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
HIBCCB3902281471 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NUJElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-10
Device Publish Date2018-11-08

Devices Manufactured by SURETEK MEDICAL

B390AR10001 - Reprocessed Suture Passer, Transosseous2024-05-27
B390C9944A1 - Reprocessed 2.9mm Full Radius Resector2024-05-20
B39044471 - Reprocessed ECTRA II, Probe Knife2024-02-29
B390AR659208401 - Reprocessed PassPort Button Cannula, 8mm x 4cm2024-02-29
B390138505101 - Reprocessed MicroNeedle 3cm2024-02-28
B3905100371131 - Reprocessed Small Tear Cross Cut Rasp, 11mm x 5mm2024-02-20
B3905100371141 - Reprocessed Large Tear Cross Cut Rasp, 14.0mm x 7.0mm2024-02-20
B390810101 - Reprocessed Carpal Tunnel Release Blade2024-02-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.