Mederi MDRF1 Generator 177-5150

GUDID 00856219002102

Mederi MDRF1 Generator Monopolar generator to be used only with Secca and Stretta catheters

MEDERI THERAPEUTICS INC.

Electrosurgical system generator
Primary Device ID00856219002102
NIH Device Record Key2c323aa8-de28-4457-8ccc-51141d72be4e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMederi MDRF1 Generator
Version Model NumberMDRF1
Catalog Number177-5150
Company DUNS022785895
Company NameMEDERI THERAPEUTICS 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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone2039309980
Emailmlucey@mederi-inc.com
Phone2039309980
Emailmlucey@mederi-inc.com
Phone2039309980
Emailmlucey@mederi-inc.com
Phone2039309980
Emailmlucey@mederi-inc.com
Phone2039309980
Emailmlucey@mederi-inc.com
Phone2039309980
Emailmlucey@mederi-inc.com
Phone2039309980
Emailmlucey@mederi-inc.com
Phone2039309980
Emailmlucey@mederi-inc.com
Phone2039309980
Emailmlucey@mederi-inc.com
Phone2039309980
Emailmlucey@mederi-inc.com
Phone2039309980
Emailmlucey@mederi-inc.com
Phone2039309980
Emailmlucey@mederi-inc.com
Phone2039309980
Emailmlucey@mederi-inc.com
Phone2039309980
Emailmlucey@mederi-inc.com
Phone2039309980
Emailmlucey@mederi-inc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100856219002102 [Primary]

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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-27

Devices Manufactured by MEDERI THERAPEUTICS INC.

00856219002003 - Secca2018-07-06 Secca Handpiece and Accessory Kit for use only with the Mederi MDRF1 Generator
00856219002102 - Mederi MDRF1 Generator2018-07-06Mederi MDRF1 Generator Monopolar generator to be used only with Secca and Stretta catheters
00856219002102 - Mederi MDRF1 Generator2018-07-06 Mederi MDRF1 Generator Monopolar generator to be used only with Secca and Stretta catheters
00856219002294 - Stretta2018-03-29 Stretta Catheter and Accessory Kit for use only with Mederi MDRF1 Generator

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