Scott's Select Non-Woven Sponges 2 x 2

Basic Information

• Brand Name: Scott's Select Non-Woven Sponges 2 x 2
• Primary DI: D77810702991
• Version / Model: 107-0299
• Catalog Number: 107-0299
• Company Name: SCOTT'S DENTAL SUPPLY L.L.C.
• Labeler DUNS: 137217043
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5000
• Record Status: Published
• Publish Date: 2024-08-27
• Public Version: 2
• Public Version Date: 2024-11-07
• Public Version Status: Update
• Public Device Record Key: 5493000e-2608-49af-b5d5-a9159563225f

Device Description

Non-Woven Dental Sponges, 2 in by 2 in squares. Features & Benefits: 4-ply non-woven sponge, Soft, smooth, strong & lint-free, high absorbency, non-sterile for general use. For more information visit: https://www.scottsdental.com/non-woven-sponges-scott-s-select.html?queryID=1fe4553484b40308b1371358d90165ad&objectID=23497&indexName=magento2_production_default_products

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
Unit of Use	D77810702990	HIBCC
Primary	D77810702991	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	2	Inch
Width	2	Inch