sam coupling patch

GUDID 00857599005097

coupling patch for use with sam wearable ultrasound device

ZETROZ SYSTEMS, LLC

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• Primary Device ID: 00857599005097
• NIH Device Record Key: fdf09afa-0104-4434-9197-de0418bc2cf1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: sam coupling patch
• Version Model Number: UB-12
• Company DUNS: 080128497
• Company Name: ZETROZ SYSTEMS, LLC
• Device Count: 10
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857599005066 [Unit of Use]
GS1	00857599005080 [Package]; Package: Case [4 Units]; In Commercial Distribution
GS1	00857599005097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130978

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-10

Devices Manufactured by ZETROZ SYSTEMS, LLC

• 00857599005202 - sam X1: 2022-10-07 The sustained acoustic medicine, (sam® X1) long-duration ultrasound device is used in the treatment of musculoskeletal injuries
• 00857599005196 - sam 2.0 Long Duration Ultrasound Device for Home Use: 2021-12-08 The sustained acoustic medicine, (sam® 2.0) long-duration ultrasound device is intended for the treatment of musculoskeletal in
• 00857599005073 - sam: 2018-07-06 wearable therapeutic ultrasound
• 00857599005097 - sam coupling patch: 2018-07-06coupling patch for use with sam wearable ultrasound device
• 00857599005097 - sam coupling patch: 2018-07-06 coupling patch for use with sam wearable ultrasound device