Reprocessed 2.3mm VAPR Wedge Electrode

GUDID B3902272031

SURETEK MEDICAL

Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed
Primary Device IDB3902272031
NIH Device Record Keyc85406f3-6e2c-4ade-b9a5-9a02f3f60a5e
Commercial Distribution StatusIn Commercial Distribution
Brand NameReprocessed 2.3mm VAPR Wedge Electrode
Version Model Number227203
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
HIBCCB3902272031 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

On-Brand Devices [Reprocessed 2.3mm VAPR Wedge Electrode]

B390227203ST1227203ST
B3902272031227203

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