Reprocessed Reflex Ultra 45 PlasmaWand

GUDID B390EICA4845011

SURETEK MEDICAL

Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed
Primary Device IDB390EICA4845011
NIH Device Record Keyac4ae9a3-cd49-40cf-a8ff-acdb4f8bcdc0
Commercial Distribution StatusIn Commercial Distribution
Brand NameReprocessed Reflex Ultra 45 PlasmaWand
Version Model NumberEICA4845-01
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
HIBCCB390EICA4845011 [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

On-Brand Devices [Reprocessed Reflex Ultra 45 PlasmaWand]

B390EICA4845011EICA4845-01
B390EIC4845011EIC4845-01

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