Angio Dynamics E6361

GUDID 26975085708364

Probe Cover 14x29.2cm, VIP Film w/ Elastic Bands & EMM Gel

EXACT MEDICAL MANUFACTURING, INC.

Body-surface ultrasound imaging transducer cover

• Primary Device ID: 26975085708364
• NIH Device Record Key: 7d0735b3-f478-4a68-92b7-2430ba72627a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Angio Dynamics
• Version Model Number: E6361
• Catalog Number: E6361
• Company DUNS: 014464314
• Company Name: EXACT MEDICAL MANUFACTURING, INC.
• Device Count: 1
• DM Exempt: true
• 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	06975085708360 [Primary]
GS1	26975085708364 [Package]; Contains: 06975085708360; Package: Case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211969

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-11
• Device Publish Date: 2023-04-03

On-Brand Devices [Angio Dynamics]

• 00850015378669: Duel Fenestrated Drape Sterile
• 00850015378645: Towel Disposable Sterile Blue
• 26975085708364: Probe Cover 14x29.2cm, VIP Film w/ Elastic Bands & EMM Gel