MytaMed

GUDID 20841019110229

Malleable Monopolar Probe with 2.25mm Ball-Tip 100mm electrode (handle to tip) 2m cable with DIN42802 Connector

Mytamed, Inc.

Open-surgery electrosurgical electrode, monopolar, single-use
Primary Device ID20841019110229
NIH Device Record Keyd7a2271a-78f8-49a0-bc77-f8399087f515
Commercial Distribution StatusIn Commercial Distribution
Brand NameMytaMed
Version Model NumberME3604-00
Company DUNS015903922
Company NameMytamed, 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

Customer Support Contacts

Phone781-834-9500
Emailkprario@ksp.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841019110225 [Primary]
GS110841019110222 [Package]
Contains: 00841019110225
Package: [10 Units]
In Commercial Distribution
GS120841019110229 [Package]
Contains: 00841019110225
Package: [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXZElectrode, Needle

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20841019110229]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2016-07-10

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