Ultrasound Gel

GUDID 00616784124537

DYNAREX CORPORATION

Coupling gel, non-sterile

• Primary Device ID: 00616784124537
• NIH Device Record Key: fce9d7ac-e67b-447f-9c55-745a31fe9805
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultrasound Gel
• Version Model Number: 1245
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784124513 [Primary]
GS1	00616784124537 [Package]; Contains: 00616784124513; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102637

FDA Product Code

• MUI: Media,Coupling,Ultrasound

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: 2016-09-24

On-Brand Devices [Ultrasound Gel]

• 00616784124735: 1247
• 00616784124537: 1245
• 00616784124339: 1243
• 00616784124131: 1241