EU Retrax Gel AS MicroPoints

Basic Information

• Brand Name: EU Retrax Gel AS MicroPoints
• Primary DI: 00310866002262
• Version / Model: 16505
• Catalog Number: 16505
• Company Name: PASCAL COMPANY, INC.
• Labeler DUNS: 009260217
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2022-06-23
• Public Version: 1
• Public Version Date: 2022-07-01
• Public Version Status: New
• Public Device Record Key: c5eaa327-fc29-4ddf-b2ef-e70246ea4608

Device Description

Topical Hemostatic 25% aluminum sulfate gel - 25 - 0.32g MicroPoint Cartridges.

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
46423	Gingival retraction solution	A liquid substance used in dentistry to induce gingival retraction by in situ impregnation of a non-medicated gingival retraction cord. It induces contraction of the upper strata of the free gingiva typically through the action of an astringent agent (e.g., aluminium chloride). This device may also induce a local stasis of gingival exudates and gingival haemorrhages. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00310866001722	GS1
Primary	00310866002262	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Weight	0.32	Gram

Storage Conditions

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