N/A OD016

GUDID 30705036003896

Optical Dilator

ETHICON ENDO-SURGERY, INC.

Endoscopic gastrointestinal stenosis dilator Endoscopic gastrointestinal stenosis dilator

• Primary Device ID: 30705036003896
• NIH Device Record Key: 449192f2-290c-4c2a-900a-bd3c43f12112
• Commercial Distribution Discontinuation: 2019-02-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: N/A
• Version Model Number: OD016
• Catalog Number: OD016
• Company DUNS: 123407392
• Company Name: ETHICON ENDO-SURGERY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com
• Phone: +1(877)384-4266
• Email: customersupport@eesus.jnj.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	20705036003899 [Primary]
GS1	30705036003896 [Package]; Contains: 20705036003899; Package: CASE [14 Units]; Discontinued: 2019-02-28; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093236

FDA Product Code

• KNQ: Dilator, esophageal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-03-01
• Device Publish Date: 2016-07-15

On-Brand Devices [N/A]

• 30705036003919: Optical Dilator
• 30705036003902: Optical Dilator
• 30705036003896: Optical Dilator