BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Kerlix

DI: 10884521083400 · Model: 7882 · Cardinal Health, Inc.

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

100

Basic Information

Brand Name: Kerlix
Primary DI: 10884521083400
Version / Model: 7882
Catalog Number: 7882
Company Name: Cardinal Health, Inc.
Labeler DUNS: 080935429
Distribution Status: In Commercial Distribution
Device Count in Pkg: 100
Record Status: Published
Publish Date: 2018-06-29
Public Version: 3
Public Version Date: 2019-02-15
Public Version Status: Update
Public Device Record Key: f79dc62b-251a-457a-823f-0c97a0f27094

Device Description

Gauze Roll,6 Ply, Large

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: No
Has Donation ID: No

Sterilization

Is Sterile: No
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
48126	Woven gauze roll, non-sterile	A non-sterile device in the form of a long strip of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521083400	GS1
Unit of Use	20884521083407	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Length,4.125,yard;
Width	4.50	Inch

Storage Conditions

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