O'Neil Intermittent Urinary Catheter ONSM14

GUDID 09350902001218

GO MEDICAL INDUSTRIES PTY. LTD.

Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit Intermittent urethral catheterization kit

• Primary Device ID: 09350902001218
• NIH Device Record Key: 6872c9e7-1427-457b-a322-1d9dc3c4fa03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: O'Neil Intermittent Urinary Catheter
• Version Model Number: 14 Gauge
• Catalog Number: ONSM14
• 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	09350902001201 [Primary]
GS1	09350902001218 [Package]; Contains: 09350902001201; Package: Carton [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