LEEP PRECISION™ Smoke Evacuation

GUDID 00888937014327

LEEP PRECISION™ Smoke Evacuation (120 VAC)

Coopersurgical, Inc.

Surgical plume evacuation system
Primary Device ID00888937014327
NIH Device Record Key65fe3594-acde-400a-bdc9-962d262cbc8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameLEEP PRECISION™ Smoke Evacuation
Version Model Number53502
Company DUNS801895244
Company NameCoopersurgical, Inc.
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100888937014327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-22

Devices Manufactured by Coopersurgical, Inc.

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00888937023817 - K-Systems2024-02-27 L126 IVF, Standard Heat Right

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