BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

CARDINAL HEALTH

DI: 20885380139786 · Model: C-XR4416S · Cardinal Health 200, LLC

View on AccessGUDID

Product Codes

1

GMDN Terms

1

Identifiers

4

Pkg Device Count

10

Basic Information

Brand Name: CARDINAL HEALTH
Primary DI: 20885380139786
Version / Model: C-XR4416S
Catalog Number: C-XR4416S
Company Name: Cardinal Health 200, LLC
Labeler DUNS: 961027315
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 10
Record Status: Published
Publish Date: 2019-06-20
Public Version: 4
Public Version Date: 2023-01-02
Public Version Status: Update
Public Device Record Key: ecfd6dd5-d56a-474a-b58b-61a63edee1de
Distribution End Date: 2022-12-31

Device Description

X-ray Detectable Sponge 4inx4in, 16-ply, sterile - Latexfree

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
GDY	GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE	General, Plastic Surgery	878.4450	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	30885380139783	GS1	PACK	64	Not in Commercial Distribution	2022-12-31
Primary	20885380139786	GS1
Package	50885380139787	GS1	CASE	2	Not in Commercial Distribution	2022-12-31
Unit of Use	10885380139789	GS1

Device Sizes

Type	Value	Unit	Text
Length	4	Inch
Width	4	Inch