Foundation DRS Solo

Basic Information

• Brand Name: Foundation DRS Solo
• Primary DI: 00850047730022
• Version / Model: FS1-1025
• Company Name: Bionova Medical Inc.
• Labeler DUNS: 080325588
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-05
• Public Version: 1
• Public Version Date: 2023-07-13
• Public Version Status: New
• Public Device Record Key: 847ca639-8ec6-49c5-877e-10b514933aa7

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: 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: Yes

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRO	Dressing, Wound, Drug	Unknown		U
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
58071	Wound regenerating polysaccharide agent	A sterile device consisting primarily of polysaccharides intended to be used to facilitate the regeneration and repair of tissues affected by a chronic wound (e.g., diabetic foot ulcer, venous ulcer, arterial ulcer, pressure ulcer, bedsore) after wound debridement. It may be a solution or sheet containing extracellular matrix regenerating agents (engineered polymers designed to promote wound matrix regeneration) and/or structural elements for native cell attachment/proliferation; devices associated with tissue application/manipulation (e.g., sterile gauze, tweezers) may be included. 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	00850047730022	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K210949	000

Device Sizes

Type	Value	Unit	Text
Length	10	Centimeter
Width	25	Centimeter