ACE TIP ELECTRODE TRA8B

GUDID 00841494104498

RODIN VARI ACE-TIP 1.5 , 1/16" BENDABLE

Ellman International

Open-surgery electrosurgical electrode, monopolar, reusable
Primary Device ID00841494104498
NIH Device Record Keyde0ea799-78f2-4b1c-ba8a-3589e789d42d
Commercial Distribution StatusIn Commercial Distribution
Brand NameACE TIP ELECTRODE
Version Model NumberTRA8B
Catalog NumberTRA8B
Company DUNS079095245
Company NameEllman International
Device Count2
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841494104498 [Primary]
GS100841494106423 [Unit of Use]

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 Date2016-09-21

On-Brand Devices [ACE TIP ELECTRODE]

00841494104498RODIN VARI ACE-TIP 1.5 , 1/16" BENDABLE
00841494104450RODIN MICROINCISION ACE-TIP 1.5"L, 1/16"
00841494104443RODIN ACETIP SET 1.5", 1/16" SHAFT, BEND
00841494104436RODIN 5/32" RND LOOP 1.5 L,1/16" .007 WR

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