Depth-Gauge FlexTrode®

GUDID 00846338008109

ELLIQUENCE, LLC

Open-surgery electrosurgical electrode, monopolar, single-use
Primary Device ID00846338008109
NIH Device Record Key6280c48f-a0e1-4198-8c7f-4e83d362fe09
Commercial Distribution StatusIn Commercial Distribution
Brand NameDepth-Gauge FlexTrode®
Version Model NumberFT-L3
Company DUNS019872358
Company NameELLIQUENCE, 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100846338008109 [Primary]

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-02-07
Device Publish Date2016-09-22

On-Brand Devices [Depth-Gauge FlexTrode®]

00846338008147FT-W
00846338008130FT-N
00846338008123FT-L7
00846338008116FT-L5
00846338008109FT-L3
00846338008093FT-B3
00846338008086FT-B2
00846338008079FT-B1
00846338001100FT-D
00846338001001FT-S

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