BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Kerlix

DI: 10884521058422 · Model: 1801 · Cardinal Health, Inc.

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

Basic Information

Brand Name: Kerlix
Primary DI: 10884521058422
Version / Model: 1801
Catalog Number: 1801
Company Name: Cardinal Health, Inc.
Labeler DUNS: 080935429
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2018-06-22
Public Version: 3
Public Version Date: 2019-02-15
Public Version Status: Update
Public Device Record Key: ec6bc6fe-19be-47f8-86f1-955398c0f433

Device Description

Bandage Roll,100% Cotton, 6 Ply, Small

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: 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
Package	20884521058429	GS1	CASE	96	In Commercial Distribution
Primary	10884521058422	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	2.25	Inch
Length	9	Feet

Storage Conditions

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