Byrd

Basic Information

• Brand Name: Byrd
• Primary DI: 00827002198593
• Version / Model: G19859
• Catalog Number: LR-PPLBES-10.0
• Company Name: Cook Vandergrift Inc.
• Labeler DUNS: 056867526
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-06-20
• Public Version Status: Update
• Public Device Record Key: 8d60c76e-6560-4047-ad6a-30439adfb516

Device Description

10.0 Fr Byrd Dilator Sheath Set (B)Polypropylene

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCC	Dilator, catheter	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46448	Fascial tissue dilator, single-use	A surgical instrument used for stretching or enlarging the fascial tissue covering a cavity, tract, or opening typically prior to the introduction of a catheter during an invasive diagnostic or interventional procedure (e.g., femoral artery catheterization). It is a rod-like device with a long, slender, hollow or solid body and a rounded nose, inflatable balloon or screw-tip at its distal end, that is available in a variety of sizes and typically made of metal or plastic. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002198593	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in dark, dry, cool place.