CARDINAL HEALTH

Basic Information

• Brand Name: CARDINAL HEALTH
• Primary DI: 10885425413645
• Version / Model: SID41A4HMA
• Catalog Number: SID41A4HMA
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-27
• Public Version: 3
• Public Version Date: 2018-07-20
• Public Version Status: Update
• Public Device Record Key: 0752ddc6-82cc-489b-8628-72d455eb9ea4

Device Description

STERILE 4" CAST PADDING PACK

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ITG	BANDAGE, CAST	Physical Medicine	890.3025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60369	General-purpose medical fibre padding, sterile	A sterile roll, sheet or preformed shape of fibres (e.g., polyester) intended to be applied to and/or compress a local area of the body for various preventative/therapeutic applications (e.g., padding under casts and compression dressings), typically over intact and healthy skin. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50885425413643	GS1	CASE	100	In Commercial Distribution
Primary	10885425413645	GS1