LEEP Micro Needle Electrode

GUDID 20888937010743

LEEP Micro Needle Electrode with 8mm Needle Electrode and 12cm Shaft

Coopersurgical, Inc.

Open-surgery electrosurgical electrode, monopolar, single-use
Primary Device ID20888937010743
NIH Device Record Key12e0d15a-5626-4b73-af85-d01f760bd5fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameLEEP Micro Needle Electrode
Version Model NumberN2512
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100888937010749 [Primary]
GS120888937010743 [Package]
Contains: 00888937010749
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 Steriletrue

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 Micro Needle Electrode]

20888937010750LEEP Micro Needle Electrode with 5mm Needle Electrode and 5.5cm Shaft
20888937010743LEEP Micro Needle Electrode with 8mm Needle Electrode and 12cm Shaft

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