sam(R) Advanced Gel Capture Patch UB-14-15W

GUDID 00857599005165

coupling patch for use with sam wearable ultrasound device

ZETROZ SYSTEMS, LLC

Skin topical coupling gel

• Primary Device ID: 00857599005165
• NIH Device Record Key: 5a1ce162-2322-4575-b83d-acc336a1c739
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: sam(R) Advanced Gel Capture Patch
• Version Model Number: UB-14
• Catalog Number: UB-14-15W
• Company DUNS: 080128497
• Company Name: ZETROZ SYSTEMS, LLC
• Device Count: 15
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857599005103 [Unit of Use]
GS1	00857599005165 [Package]; Contains: 00857599005257; Package: case [4 Units]; In Commercial Distribution
GS1	00857599005257 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191568

FDA Product Code

• PFW: Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat

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: 2024-10-18
• Device Publish Date: 2024-10-10

On-Brand Devices [sam(R) Advanced Gel Capture Patch]

• 00857599005165: coupling patch for use with sam wearable ultrasound device
• 00857599005172: coupling patch for use with sam wearable ultrasound device