MARK3

Basic Information

• Brand Name: MARK3
• Primary DI: D7966114CS10
• Version / Model: 6114CS
• Company Name: CARGUS INTERNATIONAL, INC
• Labeler DUNS: 096191093
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2019-07-10
• Public Version: 1
• Public Version Date: 2019-07-18
• Public Version Status: New
• Public Device Record Key: e0dd27a5-122b-45cf-81b0-7a6378f59536

Device Description

Self Seal 3-1/2" x 10" (3-1/2" x 9") Sterilization Pouches 20/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: 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: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRG	Wrap, Sterilization	General Hospital	880.6850	2
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	880.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60908	Sterilization container liner	A non-sterile device intended to be used to line containers used for steam or solvent sterilization (e.g., trays, wraps, pouches) to absorb moisture and protect the container's finish. It is typically made of an absorbent, non-woven material or paper. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D7966114CS10	HIBCC
Unit of Use	D7966114	HIBCC

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store In Cool Dry Place