Barbell Loop Ostomy Device BAR-2

GUDID 00860002701325

Loop Ostomy Device, Small (2-inch rod).

TOOLS FOR SURGERY, LLC

Colostomy rod

• Primary Device ID: 00860002701325
• NIH Device Record Key: 61ff0329-dfe1-4ef3-927f-41d7997030f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Barbell Loop Ostomy Device
• Version Model Number: BAR-2
• Catalog Number: BAR-2
• Company DUNS: 841842441
• Company Name: TOOLS FOR SURGERY, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Dimensions

• Length: 2 Inch
• Length: 2 Inch
• Length: 2 Inch
• Length: 2 Inch
• Length: 2 Inch
• Length: 2 Inch
• Length: 2 Inch
• Length: 2 Inch
• Length: 2 Inch
• Length: 2 Inch
• Length: 2 Inch
• Length: 2 Inch
• Length: 2 Inch
• Length: 2 Inch
• Length: 2 Inch
• Length: 2 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860002701325 [Primary]

FDA Product Code

• EZP: Rod, Colostomy

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-25
• Device Publish Date: 2023-07-17

On-Brand Devices [Barbell Loop Ostomy Device]

• 00860002701356: Loop Ostomy Device, Large (4-inch rod).
• 00860002701349: Loop Ostomy Device, Medium (3-inch rod).
• 00860002701325: Loop Ostomy Device, Small (2-inch rod).