BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Curity

DI: 00884521060503 · Model: 9022 · Cardinal Health, Inc.

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Product Codes

1

GMDN Terms

1

Identifiers

3

Pkg Device Count

200

Basic Information

Brand Name: Curity
Primary DI: 00884521060503
Version / Model: 9022
Catalog Number: 9022
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: adce1070-c911-4a6b-a601-2363252fbdbf

Device Description

All Purpose Sponges,Non-woven, 4 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
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	00884521060510	GS1	CASE	8000	In Commercial Distribution
Primary	00884521060503	GS1
Unit of Use	00884521779405	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	2	Inch
Length	2	Inch

Storage Conditions

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