TridentX

GUDID 00370858000164

NEXT SCIENCE, LLC

Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution, non-sterile Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution Antimicrobial wound irrigation solution

• Primary Device ID: 00370858000164
• NIH Device Record Key: 38306a24-41f7-49d2-8c3c-4d3c8d12baef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TridentX
• Version Model Number: MC-WW-0005-320
• Company DUNS: 043989331
• Company Name: NEXT SCIENCE, LLC
• Device Count: 320
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00370858000157 [Unit of Use]
GS1	00370858000164 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203446

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: 2022-06-09
• Device Publish Date: 2022-06-01

Devices Manufactured by NEXT SCIENCE, LLC

• 00370858000164 - TridentX: 2022-06-09
• 00370858000164 - TridentX: 2022-06-09
• 00370858000270 - SITEGUARD: 2022-03-09
• 00370858000218 - XPERIENCE: 2021-05-06
• 00370858000140 - XPERIENCE: 2021-05-06
• 00864076000292 - Bactisure™: 2020-12-25
• 00864076000216 - BlastX™: 2019-01-16
• 00370858000072 - BlastX™: 2018-10-26
• 00370858000089 - BlastX™: 2018-10-26