QKit Procedure Tray

GUDID 20888937000041

For LOOP Electrosurgical Excision Procedure - contains Lidocaine with Epinephrine

Coopersurgical, Inc.

Cervical anaesthesia kit
Primary Device ID20888937000041
NIH Device Record Key96863c5c-9c89-45eb-84f5-3d74ddcc2472
Commercial Distribution StatusIn Commercial Distribution
Brand NameQKit Procedure Tray
Version Model Number909074
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 Producttrue
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
GS100888937000047 [Primary]
GS120888937000041 [Package]
Contains: 00888937000047
Package: [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HGIElectrocautery, Gynecologic (And Accessories)

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 Date2016-02-02

Devices Manufactured by Coopersurgical, Inc.

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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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