BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

628 - Non-Stick Pads 2"x 3" - 4/unit

DI: 00766588235745 · Model: R523-574 · Certified Safety Manufacturing, Inc.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: 628 - Non-Stick Pads 2"x 3" - 4/unit
Primary DI: 00766588235745
Version / Model: R523-574
Catalog Number: R523-574
Company Name: Certified Safety Manufacturing, Inc.
Labeler DUNS: 788460483
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2025-12-17
Public Version: 1
Public Version Date: 2025-12-25
Public Version Status: New
Public Device Record Key: e1c261f2-ed3c-4c02-8379-4de748d42704

Device Description

628 - Non-Stick Pads 2"x 3" - 4/unit

Device Characteristics

Single Use: Yes
Prescription Use (Rx): No
Over the Counter (OTC): No
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: No
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
EFQ	GAUZE/SPONGE, INTERNAL	Unknown		U

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	00766588235745	GS1

Customer Contacts

Phone: +1(816)483-9090
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K940344	000