HemeRX

Basic Information

• Brand Name: HemeRX
• Primary DI: 00819235020000
• Version / Model: R-HRX
• Company Name: Sprig Oral Health Technologies, Inc.
• Labeler DUNS: 029458526
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-25
• Public Version: 1
• Public Version Date: 2022-11-02
• Public Version Status: New
• Public Device Record Key: 7e3865cc-b9b7-4fd6-ab01-fa77b9565f9b

Device Description

Hemostatic Cotton Pellets with Epinephrine

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	00819235020000	GS1

Storage Conditions

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