SureSeal 85100

GUDID 00894743001017

SureSeal Pressure Bandage, 25mm x 72mm

FACET TECHNOLOGIES, LLC

Pressure bandage, non-latex, sterile

• Primary Device ID: 00894743001017
• NIH Device Record Key: 7dd71b83-42d7-474f-9da1-a19db2df9c7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureSeal
• Version Model Number: Large
• Catalog Number: 85100
• Company DUNS: 130518376
• Company Name: FACET TECHNOLOGIES, LLC
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00089473001035 [Package]; Package: Case [20 Units]; In Commercial Distribution
GS1	00894743001017 [Primary]
GS1	01089473001010 [Unit of Use]

FDA Product Code

• KGX: Tape And Bandage, Adhesive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-10
• Device Publish Date: 2019-07-02

On-Brand Devices [SureSeal]

• 00894743001024: SureSeal Pressure Bandage, 30mm x 72mm
• 00894743001017: SureSeal Pressure Bandage, 25mm x 72mm