Reprocessed Procise XP Plasma Wand

GUDID B390EIC8872011

SURETEK MEDICAL

Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed
Primary Device IDB390EIC8872011
NIH Device Record Key12da95a3-0745-4639-84a4-97db37ade636
Commercial Distribution StatusIn Commercial Distribution
Brand NameReprocessed Procise XP Plasma Wand
Version Model NumberEIC8872-01
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
HIBCCB390EIC8872011 [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

Devices Manufactured by SURETEK MEDICAL

B3902141071 - Reprocessed Distal Rib Clear Cannula with Obturator, 5.5mm x 75mm2024-12-23
B3902141081 - Reprocessed Threaded Clear Cannula with Obturator, 5.5mm x 75mm2024-12-23
B390AR406845L1 - Reprocessed SutureLasso, 45 Deg, Curve Left2024-12-23
B390S8966561 - Reprocessed Sagittal Saw Blade, 90 x 19 x 1.27mm2024-12-23
B390AR8750131 - Reprocessed 3.7mm Cannulated Drill Bit2024-11-27
B390722901351 - Reprocessed Werewolf Irrigation Tube Set2024-11-18
B390AR65301 - Reprocessed Twist-in Cannula w/Obturator, 8.25mm x 7cm2024-10-28
B39057S000221 - Reprocessed Mica Drill Bit, 2.2mm 2024-10-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.