LEEP Macro Needle Electrode

GUDID 20888937010729

LEEP Macro Needle Electrode with 16mm Needle Electrode and 5.5cm Shaft

Coopersurgical, Inc.

Open-surgery electrosurgical electrode, monopolar, single-use
Primary Device ID20888937010729
NIH Device Record Keyc973c696-b400-4d39-9d19-94f54def83bb
Commercial Distribution StatusIn Commercial Distribution
Brand NameLEEP Macro Needle Electrode
Version Model NumberN0550
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 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

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Device Identifiers

Device Issuing AgencyDevice ID
GS100888937010725 [Primary]
GS120888937010729 [Package]
Contains: 00888937010725
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 Number4
Public Version Date2019-02-07
Device Publish Date2016-08-15

On-Brand Devices [LEEP Macro Needle Electrode]

20888937010736LEEP Macro Needle Electrode with 16mm Needle Electrode and 12cm Shaft
20888937010729LEEP Macro Needle Electrode with 16mm Needle Electrode and 5.5cm Shaft

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