Rapid Seal

Basic Information

• Brand Name: Rapid Seal
• Primary DI: 00017276237399
• Version / Model: 00017276237399
• Catalog Number: B08JZLQF59
• Company Name: Aso LLC
• Labeler DUNS: 152793493
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2021-05-18
• Public Version: 1
• Public Version Date: 2021-05-26
• Public Version Status: New
• Public Device Record Key: 9d756336-2c83-4795-8adb-97719fa304f6

Device Description

Rapid Seal, Antibacterial Wound Gel, 28 uses, 2 tubes, 0.5 FL OZ each (14 ml)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• 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
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
65341	Chitosan haemostatic agent, home-use	A non-bioabsorbable device that includes chitosan (a polysaccharide derived from chitin, the structural element in the exoskeleton of crustaceans) as a principal component, intended to be applied by a layperson at home to superficial wounds (e.g., minor cuts, lacerations, abrasions) to produce a rapid haemostasis by forming a robust plug of gel which is removed after use; it is not intended for severe wounds/emergency situations. The chitosan may be intended to provide antibacterial activity, and is available in a variety of forms (e.g., fine particles in a pouch, coated on gauze). 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	60017276237391	GS1
Primary	00017276237399	GS1
Package	20017276237393	GS1	case	72	In Commercial Distribution

Customer Contacts

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