LEEP PRECISION™ Smoke Evacuator

GUDID 00888937026597

LEEP PRECISION™ Smoke Evacuator (230 VAC)

Coopersurgical, Inc.

Surgical plume evacuation system
Primary Device ID00888937026597
NIH Device Record Key25717cee-c3e0-4525-a038-355ff2fc1a9e
Commercial Distribution StatusIn Commercial Distribution
Brand NameLEEP PRECISION™ Smoke Evacuator
Version Model Number53503
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
GS100888937026597 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-25
Device Publish Date2024-06-17

Devices Manufactured by Coopersurgical, Inc.

00888937018240 - Lone Star® IRI Delivery2024-07-01 Lone Star® IRI Delivery Tube Replacement
00888937026597 - LEEP PRECISION™ Smoke Evacuator2024-06-25LEEP PRECISION™ Smoke Evacuator (230 VAC)
00888937026597 - LEEP PRECISION™ Smoke Evacuator2024-06-25 LEEP PRECISION™ Smoke Evacuator (230 VAC)
60888937027176 - ERPeak2024-04-18 IVD Sample kit
60888937027183 - ERPeak2024-04-18 IVD Sample kit
60888937027190 - ERPeak2024-04-18 IVD Sample kit
60888937027206 - ERPeak2024-04-18 IVD Sample kit
00888937026870 - Mara Console2024-03-21 Mara Console- Endometrial Ablation
00888937023817 - K-Systems2024-02-27 L126 IVF, Standard Heat Right

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