MEDLINE

Basic Information

• Brand Name: MEDLINE
• Primary DI: 10888277733213
• Version / Model: DYNDA2447
• Catalog Number: DYNDA2447
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-11
• Public Version: 1
• Public Version Date: 2020-05-19
• Public Version Status: New
• Public Device Record Key: 44acac73-19e5-4aa7-a7f1-2ab28d5fbf1c

Device Description

LIVER RENAL BIOPSY TRAY- CHOICE

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PYA	Liver biopsy kit	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47611	Liver biopsy procedure kit	A collection of sterile devices, equipment, and supplies used to obtain a tissue specimen from the liver of a patient for histological analysis. It typically contains a biopsy needle, a stylet, syringes, and a scalpel. The specimen is aspirated through the needle when in situ using the syringe. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20888277733210	GS1	CASE	15	In Commercial Distribution
Primary	10888277733213	GS1

Customer Contacts

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