Reprocessed Colorado MicroNeedle, 3" Straight

GUDID B390E10331

SURETEK MEDICAL

Endoscopic electrosurgical handpiece/electrode, monopolar, reprocessed
Primary Device IDB390E10331
NIH Device Record Keya04f6ce6-50a0-499f-8146-1d15ec9b56aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameReprocessed Colorado MicroNeedle, 3" Straight
Version Model NumberE1033
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
HIBCCB390E10331 [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 Date2022-03-21
Device Publish Date2022-03-11

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