BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Kerlix

DI: 10884527020829 · Model: 4031 · Cardinal Health, Inc.

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Product Codes

1

GMDN Terms

1

Identifiers

3

Pkg Device Count

5

Basic Information

Brand Name: Kerlix
Primary DI: 10884527020829
Version / Model: 4031
Catalog Number: 4031
Company Name: Cardinal Health, Inc.
Labeler DUNS: 080935429
Distribution Status: In Commercial Distribution
Device Count in Pkg: 5
Record Status: Published
Publish Date: 2018-06-30
Public Version: 3
Public Version Date: 2021-08-24
Public Version Status: Update
Public Device Record Key: 01cf3ce1-df5f-43bd-9dd5-c9df9c0cc0a4

Device Description

X-Ray Detectable Laparotomy Sponges,Tray Pack

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: 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: 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	20884527020826	GS1	CASE	100	In Commercial Distribution
Primary	10884527020829	GS1
Unit of Use	30884527020823	GS1

Customer Contacts

Phone: +1(508)261-8000
Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Width	17	Inch
Length	26	Inch

Storage Conditions

Type: Special Storage Condition, Specify
Special Conditions: This side up;