Surgaflex

Basic Information

• Brand Name: Surgaflex
• Primary DI: 00850019162202
• Version / Model: SF0420
• Company Name: IMBED BIOSCIENCES, INC
• Labeler DUNS: 962084500
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-02
• Public Version: 2
• Public Version Date: 2023-07-26
• Public Version Status: Update
• Public Device Record Key: b2e1d62d-a99e-4776-8839-5f27aeedc328

Device Description

Surgaflex™ is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. Surgaflex™ is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: Yes
• 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
48073	Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial	A wound covering, typically made of a hydrocolloid, intended to produce a water-absorbent gel upon contact with wound exudate, and that contains an antimicrobial agent [e.g., silver (Ag)]. It is intended to protect and facilitate healing of minor cuts, scrapes, abrasions, lacerations, blisters, and scalds by absorbing wound exudates while creating a moist wound-healing environment and reducing microbial colonization within the dressing. The device is typically in the form of a flat sheet/film and is intended for use in the home or a clinical setting. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850019162202	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K153756	000

Device Sizes

Type	Value	Unit	Text
Area/Surface Area	80	Square centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius