SynePure Wound Cleanser

Basic Information

• Brand Name: SynePure Wound Cleanser
• Primary DI: 00852181005301
• Version / Model: 8 oz
• Company Name: SYNEDGEN, INC.
• Labeler DUNS: 830276353
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-01
• Public Version: 2
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 2100f69e-73cf-48c5-8465-6b22ddb4e745

Device Description

SynePure™ Wound Cleanser is intended for the cleansing and rinsing of dermal wounds such as pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor irritations of the skin.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• 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: No

Sterilization

• Is Sterile: No
• 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
58931	Non-antimicrobial wound irrigation solution, multiple solute	A solution of electrolytes sometimes with other compounds [not limited to sodium chloride (NaCl), therefore not a saline solution], intended to be used to irrigate and clean a superficial skin wound to support natural healing; it is not intended to provide antimicrobial activity. The device may be supplied in a plastic container with a spray nozzle and is intended to be used in the home or healthcare facility. 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	00852181005301	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K143444	000

Device Sizes

Type	Value	Unit	Text
Total Volume	8	Fluid Ounce