Reprocessed OPES Aspirating Ablator, 3mm, 90 Deg

GUDID B390AR9803A901

SURETEK MEDICAL

Endoscopic electrosurgical handpiece/electrode, monopolar, reprocessed
Primary Device IDB390AR9803A901
NIH Device Record Key7a3edbe9-1faf-4424-beb4-83ef16240fdd
Commercial Distribution StatusIn Commercial Distribution
Brand NameReprocessed OPES Aspirating Ablator, 3mm, 90 Deg
Version Model NumberAR-9803A-90
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
HIBCCB390AR9803A901 [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 Date2016-09-02

On-Brand Devices [Reprocessed OPES Aspirating Ablator, 3mm, 90 Deg]

B390AR9803A901AR-9803A-90
B390AR9703A901AR-9703A-90

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