BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

Premium Non-Woven Sponges

DI: 10732224005208 · Model: ENCNW4K · CROSSTEX INTERNATIONAL, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

200

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Basic Information

Brand Name: Premium Non-Woven Sponges
Primary DI: 10732224005208
Version / Model: ENCNW4K
Catalog Number: ENCNW4K
Company Name: CROSSTEX INTERNATIONAL, INC.
Labeler DUNS: 057728685
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 200
Record Status: Published
Publish Date: 2023-07-17
Public Version: 4
Public Version Date: 2025-10-24
Public Version Status: Update
Public Device Record Key: 5030a444-84a1-4f07-92ff-94f3be22ac3d
Distribution End Date: 2025-10-23

Device Description

2" x 2", 4-Ply

Device Characteristics

Single Use: Yes
Prescription Use (Rx): No
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: Yes
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: Yes
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; in some cases, the device’s packaging may be used as a disposable tray. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10732224005208	GS1
Unit of Use	00732224005201	GS1

Customer Contacts

Phone: +1(800)483-7433
Email: [email protected]