TridentX

GUDID 00370858000164

NEXT SCIENCE, LLC

Antimicrobial wound irrigation solution, non-sterile

• 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

• 00370858000010 - BIOWASH Surgical Irrigation: 2024-08-08
• 00370858000058 - BIOWASH Surgical Irrigation: 2024-08-08
• 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