Reprocessed VAPR Cool Pulse Electrode, Hand Contro

GUDID B3902281471

SURETEK MEDICAL

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

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