BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Dermacea

DI: 10884521084261 · Model: 441203 · Cardinal Health, Inc.

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Product Codes

1

GMDN Terms

1

Identifiers

3

Pkg Device Count

200

Basic Information

Brand Name: Dermacea
Primary DI: 10884521084261
Version / Model: 441203
Catalog Number: 441203
Company Name: Cardinal Health, Inc.
Labeler DUNS: 080935429
Distribution Status: In Commercial Distribution
Device Count in Pkg: 200
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: b48807f0-625e-45ac-93e1-627f74df2cfd

Device Description

USP Type VII Gauze,8 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: 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
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	20884521084268	GS1	CASE	5000	In Commercial Distribution
Primary	10884521084261	GS1
Unit of Use	30884521084265	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	2	Inch
Width	2	Inch

Storage Conditions

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