SheathesGel

GUDID 10842418102122

Internally Sterile, 20ml Single-Use Packet of Ultrasound Gel

SHEATHING TECHNOLOGIES, INC.

Topical coupling gel, sterile

• Primary Device ID: 10842418102122
• NIH Device Record Key: cf9eb550-9648-4ef3-9a06-b24661027824
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SheathesGel
• Version Model Number: 60001
• Company DUNS: 806806220
• Company Name: SHEATHING TECHNOLOGIES, INC.
• Device Count: 25
• 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	00842418102125 [Unit of Use]
GS1	10842418102122 [Primary]
GS1	20842418102129 [Package]; Package: CASE [3 Units]; In Commercial Distribution
GS1	30842418102126 [Package]; Package: CASE [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130041

FDA Product Code

• MUI: Media,Coupling,Ultrasound

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-06-10
• Device Publish Date: 2017-08-22

On-Brand Devices [SheathesGel]

• 10842418102122: Internally Sterile, 20ml Single-Use Packet of Ultrasound Gel
• 20842418102051: Sterile, 20ml Single-Use Packet of Ultrasound Gel
• 20842418102037: Non-Sterile, 20ml Single-Use Packet of Ultrasound Gel
• 20842418100767: Sterile, 20ml Single-Use Packet of Ultrasound Gel Inside Chevron Pouch