ACE-TIP ELECTRODE TNAEE285

GUDID 00841494103385

HLTZ TONSILLOTOMY 12MM LOOP, .010 WIRE

Ellman International

Open-surgery electrosurgical electrode, monopolar, reusable
Primary Device ID00841494103385
NIH Device Record Keyc4089aba-cef2-483a-8054-9054c02cd112
Commercial Distribution StatusIn Commercial Distribution
Brand NameACE-TIP ELECTRODE
Version Model NumberTNAEE285
Catalog NumberTNAEE285
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
GS100841494103385 [Primary]
GS100841494105945 [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]

00841494104986VARI-TIP ACE-TIP 1/16", BENDABLE
00841494103408HLTZ TONSILLOTOMY ACE-TIP SET OF 3, 1/16
00841494103392HLTZ TONSILLOTOMY 15MM LOOP, .010 WIRE
00841494103385HLTZ TONSILLOTOMY 12MM LOOP, .010 WIRE
00841494103033EMPIRE MICROINCISION ACE-TIP 1/16" SHAFT
008414941017635MM TAPERED BALL ACE-TIP 1/16", BENDABLE
008414941016023MM TAPERED BALL ACE-TIP 1/16", BENDABLE
008414941015033/8" RND LOOP ACE-TIP REGULAR WIRE,1/16"
008414941014973/8" RND LOOP ACE-TIP FINE WIRE,1/16"
008414941014423/8" NEEDLE, 1/32" DIA. ACE-TIP, 1/16"
008414941013983/8" NEEDLE ACE-TIP REGULAR WIRE, 1/16"
008414941012372MM COAGULATING BALL ACE-TIP 1/16", BEND
008414941011451CM NEEDLE, 3"CURVED SLEEVE ACE-TIP,1/16
008414941009021/4" RND LOOP ACE-TIP REGULAR WIRE, 1/16
008414941008961/4" RND LOOP ACE-TIP FINE WIRE, 1/16"
008414941008031/4" TRIANGLE ACE-TIP FINE WIRE, 1/16"

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.