SynePure Wound Cleanser

GUDID 00852181005295

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.

SYNEDGEN, INC.

Non-antimicrobial wound irrigation solution, multiple solute, non-sterile

• Primary Device ID: 00852181005295
• NIH Device Record Key: 187ea90a-67f2-4ea3-9088-b15b6f7febab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SynePure Wound Cleanser
• Version Model Number: 4oz
• Company DUNS: 830276353
• Company Name: SYNEDGEN, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com
• Phone: 855-774-7962
• Email: info@synedgen.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852181005295 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143444

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-09
• Device Publish Date: 2020-10-01

On-Brand Devices [SynePure Wound Cleanser]

• 00852181005301: SynePure™ Wound Cleanser is intended for the cleansing and rinsing of dermal wounds such as pr
• 00852181005295: SynePure™ Wound Cleanser is intended for the cleansing and rinsing of dermal wounds such as pr