Isolator Mini

Basic Information

• Brand Name: Isolator Mini
• Primary DI: 00310866002538
• Version / Model: 28120
• Catalog Number: 28120
• Company Name: PASCAL COMPANY, INC.
• Labeler DUNS: 009260217
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2022-12-07
• Public Version: 1
• Public Version Date: 2022-12-15
• Public Version Status: New
• Public Device Record Key: 87ff9bd3-ba6d-48e4-be98-055c83b1e31e

Device Description

Pack of 25 Great for sealants & multiple situations when a dry field is necessary. Adapts to cotton roll sizes 1,2 & 3. Maintains a dry field without restricting access and visibility. Eliminates patient discomfort.

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
Unit of Use	00310866001746	GS1
Primary	00310866002538	GS1

Customer Contacts

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