BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Dermacea

DI: 10884527020997 · Model: 441404 · Cardinal Health, Inc.

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Product Codes

1

GMDN Terms

1

Identifiers

4

Pkg Device Count

2

Basic Information

Brand Name: Dermacea
Primary DI: 10884527020997
Version / Model: 441404
Catalog Number: 441404
Company Name: Cardinal Health, Inc.
Labeler DUNS: 080935429
Distribution Status: In Commercial Distribution
Device Count in Pkg: 2
Record Status: Published
Publish Date: 2018-06-27
Public Version: 3
Public Version Date: 2021-08-24
Public Version Status: Update
Public Device Record Key: 26f21fe7-9ade-41c9-ab76-6533e2e12667

Device Description

Non-woven Sponges,6 Ply

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: Yes
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRL	FIBER, MEDICAL, ABSORBENT	General Hospital	880.5300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48131	Non-woven gauze pad	A non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884527020994	GS1	PACK_OR_INNER_PACK	50	In Commercial Distribution
Primary	10884527020997	GS1
Package	30884527020991	GS1	CASE	600	In Commercial Distribution
Unit of Use	40884527020998	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	3	Inch
Length	4	Inch

Storage Conditions

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