Plasma Concepts Professional Plasma Tip Treatment Pack CS-500001

GUDID 08600103856034

Electrode Tip - Professional Plasma Tip Treatment Pack (Single)

Med Pen Concepts LLC

Electrosurgical handpiece, single-use
Primary Device ID08600103856034
NIH Device Record Key61c26c9c-2c76-4f54-a787-95d8f2a8d439
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlasma Concepts Professional Plasma Tip Treatment Pack
Version Model NumberProfessional Tip Treatment Pack
Catalog NumberCS-500001
Company DUNS119006347
Company NameMed Pen Concepts LLC
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(800) 274-5684
Emailsupport@plasmaconcepts.com
Phone(800) 274-5684
Emailsupport@plasmaconcepts.com
Phone(800) 274-5684
Emailsupport@plasmaconcepts.com
Phone(800) 274-5684
Emailsupport@plasmaconcepts.com
Phone(800) 274-5684
Emailsupport@plasmaconcepts.com
Phone(800) 274-5684
Emailsupport@plasmaconcepts.com
Phone(800) 274-5684
Emailsupport@plasmaconcepts.com
Phone(800) 274-5684
Emailsupport@plasmaconcepts.com
Phone(800) 274-5684
Emailsupport@plasmaconcepts.com
Phone(800) 274-5684
Emailsupport@plasmaconcepts.com
Phone(800) 274-5684
Emailsupport@plasmaconcepts.com
Phone(800) 274-5684
Emailsupport@plasmaconcepts.com
Phone(800) 274-5684
Emailsupport@plasmaconcepts.com
Phone(800) 274-5684
Emailsupport@plasmaconcepts.com
Phone(800) 274-5684
Emailsupport@plasmaconcepts.com
Phone(800) 274-5684
Emailsupport@plasmaconcepts.com
Phone(800) 274-5684
Emailsupport@plasmaconcepts.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108600103856034 [Primary]
GS118600103856031 [Package]
Package: Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-23
Device Publish Date2023-08-15

Devices Manufactured by Med Pen Concepts LLC

08600103856010 - PlasmaMD2023-08-24 Electrosurgical Handpiece
08600103856027 - Plasma+2023-08-23 Electrosurgical Handpiece
08600103856034 - Plasma Concepts Professional Plasma Tip Treatment Pack2023-08-23Electrode Tip - Professional Plasma Tip Treatment Pack (Single)
08600103856034 - Plasma Concepts Professional Plasma Tip Treatment Pack2023-08-23 Electrode Tip - Professional Plasma Tip Treatment Pack (Single)

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