Procellera Single Layer

Basic Information

• Brand Name: Procellera Single Layer
• Primary DI: 00894318002609
• Version / Model: 2" x 5"
• Catalog Number: VSR-0205
• Company Name: Vomaris Wound Care, Inc.
• Labeler DUNS: 080126901
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-18
• Public Version: 1
• Public Version Date: 2022-11-28
• Public Version Status: New
• Public Device Record Key: 3792ef02-3829-4196-bc02-4dd721446465

Device Description

Procellera Single Layer Rx, 2" x 5"

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
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
62983	Bioelectric wound dressing	A sterile wound covering containing microcell batteries [e.g., based on silver (Ag)/zinc(Zn)] designed to mimic a physiologic electric field in the presence of a conductive medium (e.g. saline, hydrogel, or wound exudate) to destroy microbial pathogens (antimicrobial) at the dressing surface and help reduce the risk of wound infection. It is intended to cover partial- and full-thickness wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and help create a moist wound-healing environment. It is in the form of a flat sheet/pad, may be designed to absorb wound exudates, but does not have wound-nonadherent properties. 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	00894318002609	GS1
Package	10894318002606	GS1	Box	10	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K160783	000