Personal Catheter™ Intermittent Catheter 63516

GUDID 10801741069250

Personal Catheter™ Intermittent Catheter Antibacterial Hydrophilic Coated Silicone, Male

C. R. Bard, Inc.

Single-administration urethral drainage catheter Single-administration urethral drainage catheter

• Primary Device ID: 10801741069250
• NIH Device Record Key: 83e1cab1-385e-4aa7-b7c2-d7e0c16a9ac7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Personal Catheter™ Intermittent Catheter
• Version Model Number: 63516
• Catalog Number: 63516
• Company DUNS: 016898496
• Company Name: C. R. Bard, 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)526-4455
• Email: medical.services@crbard.com
• Phone: +1(800)526-4455
• Email: medical.services@crbard.com

Device Dimensions

• Catheter Gauge: 16 French
• Catheter Gauge: 16 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741069253 [Primary]
GS1	10801741069250 [Package]; Contains: 00801741069253; Package: CA [30 Units]; In Commercial Distribution
GS1	20801741069257 [Package]; Package: CA [180 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033477

FDA Product Code

• MJC: CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES

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: 2018-07-06
• Device Publish Date: 2016-07-23

On-Brand Devices [Personal Catheter™ Intermittent Catheter]

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