MytaMed

GUDID 20841019110236

Single Use Monopolar Suction Coagulator 10 French with 10 ft (3m) Monopolar Cord

Mytamed, Inc.

Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Primary Device ID20841019110236
NIH Device Record Key88505271-7dbe-4258-a4e0-4105d68ade37
Commercial Distribution StatusIn Commercial Distribution
Brand NameMytaMed
Version Model Number40-6000
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
GS100841019110232 [Primary]
GS110841019110239 [Package]
Contains: 00841019110232
Package: [10 Units]
In Commercial Distribution
GS120841019110236 [Package]
Contains: 00841019110232
Package: [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAMApparatus, Electrosurgical

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20841019110236]

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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