N/A OD018

GUDID 30705036003902

Optical Dilator

ETHICON ENDO-SURGERY, INC.

Endoscopic gastrointestinal stenosis dilator
Primary Device ID30705036003902
NIH Device Record Keyc7213325-8a0c-497e-abc6-6c1a0ece2ba3
Commercial Distribution Discontinuation2019-02-28
Commercial Distribution StatusNot in Commercial Distribution
Brand NameN/A
Version Model NumberOD018
Catalog NumberOD018
Company DUNS123407392
Company NameETHICON ENDO-SURGERY, INC.
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS120705036003905 [Primary]
GS130705036003902 [Package]
Contains: 20705036003905
Package: CASE [14 Units]
Discontinued: 2019-02-28
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNQDilator, esophageal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-03-01
Device Publish Date2016-07-15

On-Brand Devices [N/A]

30705036003919Optical Dilator
30705036003902Optical Dilator
30705036003896Optical Dilator

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