Ultrasound Probe Cover Biopsy Needle Guide Kit

GUDID 10848340017541

Disposable Probe Cover Accessories

ADVANCE MEDICAL DESIGNS, INC.

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• Primary Device ID: 10848340017541
• NIH Device Record Key: 9a7bf857-0b16-47d7-afb7-1b8abbfb9b42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultrasound Probe Cover Biopsy Needle Guide Kit
• Version Model Number: 28-EG197
• Company DUNS: 130785884
• Company Name: ADVANCE MEDICAL DESIGNS, 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848340017544 [Primary]
GS1	10848340017541 [Package]; Contains: 00848340017544; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011265

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

Sterilization

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

[10848340017541]

Ethylene Oxide

[10848340017541]

Ethylene Oxide

[10848340017541]

Ethylene Oxide

[10848340017541]

Ethylene Oxide

[10848340017541]

Ethylene Oxide

[10848340017541]

Ethylene Oxide

[10848340017541]

Ethylene Oxide

[10848340017541]

Ethylene Oxide

[10848340017541]

Ethylene Oxide

[10848340017541]

Ethylene Oxide

[10848340017541]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-11
• Device Publish Date: 2022-08-03

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