Harmonic ACE HARH36

GUDID 40705036014622

Harmonic ACE +7 Laparoscopic Shears Advanced Hemostasis 5mm Diameter 36cm Shaft length For Use With Gray Hand Piece Only

ETHICON ENDO-SURGERY, LLC

Soft-tissue ultrasonic surgical system handpiece tip, single-use
Primary Device ID40705036014622
NIH Device Record Key5ee79332-fb15-4ca3-aae3-3adbf3c95587
Commercial Distribution StatusIn Commercial Distribution
Brand NameHarmonic ACE
Version Model NumberHARH36
Catalog NumberHARH36
Company DUNS044606982
Company NameETHICON ENDO-SURGERY, LLC
Device Count6
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com
Phone+1(877)384-4266
Emailcustomersupport@eesus.jnj.com

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -22 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110705036014621 [Unit of Use]
GS120705036014628 [Primary]
GS130705036014625 [Package]
Contains: 20705036014628
Package: CASE [24 Units]
In Commercial Distribution
GS140705036014622 [Package]
Contains: 20705036014628
Package: CASE [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFLInstrument, ultrasonic surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-15

On-Brand Devices [Harmonic ACE]

40705036014677Harmonic ACE +7 Shears Advanced Hemostasis 5mm Diameter 23cm Shaft length For Use With Gray Han
40705036014639Harmonic ACE +7 Laparoscopic Shears Advanced Hemostasis 5mm Diameter 45cm Shaft length For Use
40705036014622Harmonic ACE +7 Laparoscopic Shears Advanced Hemostasis 5mm Diameter 36cm Shaft length For Use
30705036014441Harmonic Ace 5mm Diameter Shears 36cm Shaft length + Adaptive Tissue Technology for use with Gen
30705036014434Harmonic Ace 5mm Diameter Shears 23cm Shaft length + Adaptive Tissue Technology for use with Gen
30705036000970Harmonic Ace Curved Shears with Ergonomic Handle Hand Control and Torque Wrench
30705036000932Harmonic Ace Curved Shears with Ergonomic Handle Hand Control and Torque Wrench
30705036000895Harmonic Ace Curved Shears with Ergonomic Handle Hand Control and Torque Wrench
30705036000888Harmonic Ace Curved Shears with Scissor Handle and Hand Control

Trademark Results [Harmonic ACE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HARMONIC ACE
HARMONIC ACE
78466193 3335939 Live/Registered
Johnson & Johnson
2004-08-12

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