MARK3

Basic Information

• Brand Name: MARK3
• Primary DI: D7961330GR0
• Version / Model: 1330GR
• Company Name: CARGUS INTERNATIONAL, INC
• Labeler DUNS: 096191093
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-27
• Public Version: 2
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: 3c8411a4-dd64-431b-b98d-a1bba043a37d

Device Description

Tray Covers Green Ritter B 8-1/2" x 12-1/4" 1,000/cs. - MARK3

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NRD	Unit, Operative Dental, Accessories	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63780	Laboratory instrument/analyser absorbent liner IVD	A non-sterile sheet or pad made from natural materials (e.g., cotton, paper) intended to be used to absorb spilt liquids onboard a liquid-handling laboratory analyser or instrument. It is intended to create a barrier to contamination, help reduce cleaning requirements, and protect the analyser/instrument from damage (e.g., corrosion). The device is typically placed inside a tray, bin, or other specific area of the analyser/instrument where liquids are likely to spill or splash during in vitro diagnostic procedures. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D7961330GR0	HIBCC

Storage Conditions

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