Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53512G

GUDID 20801741069707

Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve, Antibacterial Hydrophilic Coated Silicone, Male

C. R. Bard, Inc.

Single-administration urethral drainage catheter

• Primary Device ID: 20801741069707
• NIH Device Record Key: 86cf9efc-4925-45b2-9750-477de276117d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve
• Version Model Number: 53512G
• Catalog Number: 53512G
• 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: 12 French
• Catheter Gauge: 12 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741069703 [Primary]
GS1	10801741069700 [Package]; Contains: 00801741069703; Package: CA [30 Units]; In Commercial Distribution
GS1	20801741069707 [Package]; Contains: 10801741069700; 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 [Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve]

• 10801741069809: Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve Hydrophilic Coated Silicone, Male
• 10801741069793: Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve Hydrophilic Coated Silicone, Male
• 10801741069786: Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve Hydrophilic Coated Silicone, Male
• 10801741069779: Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve Hydrophilic Coated Silicone, Male
• 10801741069762: Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve Hydrophilic Coated Silicone, Male
• 10801741069755: Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve Hydrophilic Coated Silicone, Male
• 10801741069748: Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve, Antibacterial Hydrophilic Coated Silic
• 20801741069738: Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve, Antibacterial Hydrophilic Coated Silic
• 10801741069724: Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve, Antibacterial Hydrophilic Coated Silic
• 20801741069714: Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve, Antibacterial Hydrophilic Coated Silic
• 20801741069707: Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve, Antibacterial Hydrophilic Coated Silic
• 10801741069694: Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve Hydrophilic Coated Silicone, Pediatric
• 20801741069684: Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve Hydrophilic Coated Silicone, Pediatric
• 10801741069670: Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve Hydrophilic Coated Silicone, Pediatric