Retrax Pellets

Basic Information

• Brand Name: Retrax Pellets
• Primary DI: 00310866000800
• Version / Model: 12400
• Catalog Number: 12400
• Company Name: PASCAL COMPANY, INC.
• Labeler DUNS: 009260217
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 350
• Record Status: Published
• Publish Date: 2019-01-31
• Public Version: 1
• Public Version Date: 2019-03-04
• Public Version Status: New
• Public Device Record Key: e9d76b63-20da-499c-a73a-0fad20f4c6b4

Device Description

Hemostatic cotton pellets with aluminum sulfate

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MVL	Cord, Retraction	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
46037	Gingival retraction cord, medicated	A medicated, cotton string used to temporarily hold off the gingiva during abutment preparation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00310866000800	GS1
Unit of Use	00310866002019	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit