Scott's Select Cotton Rolls

Basic Information

• Brand Name: Scott's Select Cotton Rolls
• Primary DI: D77810701991
• Version / Model: 107-0199
• Catalog Number: 107-0199
• Company Name: SCOTT'S DENTAL SUPPLY L.L.C.
• Labeler DUNS: 137217043
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2000
• Record Status: Published
• Publish Date: 2024-08-27
• Public Version: 1
• Public Version Date: 2024-09-04
• Public Version Status: New
• Public Device Record Key: 5629a5dc-efda-4935-a846-812037381cd1

Device Description

Absorbent white cotton fiber rolls for general dental use. Non-sterile. For more information visit: https://www.scottsdental.com/cotton-rolls-scott-s-select.html?queryID=c84bb669eb80bf01c9cfb9b0c8556ce9&objectID=23475&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
EFN	Cotton, Roll	Dental	872.6050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31815	Dental cotton roll	A non-sterile designed as an absorbent, non-sterile mass of cotton or man-made fibres formed as a small, short, hard-packed cylinder (a roll) that is used as a saliva absorber and intended to absorb moisture from the oral cavity during dental procedures. It may also be used as a packing between the lip/cheek and the gum to give better examination/operative exposure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D77810701992	HIBCC	Case	6	In Commercial Distribution
Primary	D77810701991	HIBCC
Unit of Use	D77810701990	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	1.25	Inch
Outer Diameter	.375	Inch