O'Neil Intermittent Urinary Catheter ONSM08

GUDID 09350902001157

GO MEDICAL INDUSTRIES PTY. LTD.

Intermittent urethral catheterization kit

• Primary Device ID: 09350902001157
• NIH Device Record Key: b46715e4-2dda-4cb9-a354-69beb311466f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: O'Neil Intermittent Urinary Catheter
• Version Model Number: 8 Gauge
• Catalog Number: ONSM08
• Company DUNS: 757634266
• Company Name: GO MEDICAL INDUSTRIES PTY. LTD.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09350902001140 [Primary]
GS1	09350902001157 [Package]; Contains: 09350902001140; Package: [200 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993651

FDA Product Code

• GBM: Catheter, Urethral

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-11-28
• Device Publish Date: 2017-05-17