SureSeal

Basic Information

• Brand Name: SureSeal
• Primary DI: 00894743001017
• Version / Model: Large
• Catalog Number: 85100
• Company Name: FACET TECHNOLOGIES, LLC
• Labeler DUNS: 130518376
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2019-07-02
• Public Version: 1
• Public Version Date: 2019-07-10
• Public Version Status: New
• Public Device Record Key: 7dd71b83-42d7-474f-9da1-a19db2df9c7e

Device Description

SureSeal Pressure Bandage, 25mm x 72mm

Device Characteristics

• Single Use: Yes
• 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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGX	Tape And Bandage, Adhesive	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59022	Pressure bandage, non-latex, sterile	A sterile strip or roll of fabric or plastic material (non-latex) intended to be applied to and compress a local area of the body for various preventative/therapeutic applications (e.g., to stop bleeding, prevent oedema, provide support for varicose veins). It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00894743001017	GS1
Unit of Use	01089473001010	GS1
Package	00089473001035	GS1	Case	20	In Commercial Distribution