CARDINAL HEALTH

Basic Information

• Brand Name: CARDINAL HEALTH
• Primary DI: 10885380133794
• Version / Model: C-SG44121S
• Catalog Number: C-SG44121S
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-07
• Public Version: 4
• Public Version Date: 2023-01-02
• Public Version Status: Update
• Public Device Record Key: 23c546ac-9589-43d9-b213-83dc82f0eee6
• Distribution End Date: 2022-12-31

Device Description

Cardinal Health Premium Gauze Sponge; 12-Ply; USP Type VII Gauze

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• 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: No
• 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
NAB	Gauze / sponge,nonresorbable for external use	General, Plastic Surgery	878.4014	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38496	Radiopaque woven surgical sponge	A non-medicated device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50885380133792	GS1	CASE	12	Not in Commercial Distribution	2022-12-31
Package	20885380133791	GS1	BOX	100	Not in Commercial Distribution	2022-12-31
Primary	10885380133794	GS1

Device Sizes

Type	Value	Unit	Text
Length	4	Inch
Height	4	Inch