FloraSeal Mini

Basic Information

• Brand Name: FloraSeal Mini
• Primary DI: M495FS035T1
• Version / Model: FS035T
• Catalog Number: FS-035T
• Company Name: ADHEZION BIOMEDICAL, LLC
• Labeler DUNS: 827716437
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2021-01-07
• Public Version: 1
• Public Version Date: 2021-01-15
• Public Version Status: New
• Public Device Record Key: b0a5547a-107c-407a-a723-a76a1e9d7561

Device Description

FloraSeal Mini Microbial Sealant

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: Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NZP	Sealant, Microbial	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46700	Surgical skin microbial sealant	A sterile synthetic substance (e.g., cyanoacrylate) intended to be applied to the skin of a patient prior to surgical incision (typically over commonly used preoperative skin preparation and with or without standard surgical draping) to, upon polymerization, bond to the skin and fix microbes, reducing the risk of skin flora contamination during the surgical procedure. It is typically contained within a disposable, ready-to-use applicator. 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	M495FS035T0	HIBCC
Primary	M495FS035T1	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K083354	000

Device Sizes

Type	Value	Unit	Text
Total Volume	.35	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 86 Degrees Fahrenheit