ENSEAL X1 NSLX120L

GUDID 20705036015021

ENSEAL 20 cm shaft, Large Jaw

ETHICON ENDO-SURGERY, LLC

Open-surgery electrosurgical handpiece/electrode, bipolar, single-use
Primary Device ID20705036015021
NIH Device Record Keyb5f9d939-ef79-49c0-8cf5-9a5e11b81183
Commercial Distribution StatusIn Commercial Distribution
Brand NameENSEAL X1
Version Model NumberNSLX120L
Catalog NumberNSLX120L
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 HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS110705036015024 [Unit of Use]
GS120705036015021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HGIELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-07-08
Device Publish Date2017-02-21

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