Ultrasound Probe Cover Biopsy Needle Guide Kit

GUDID 10848340016964

Disposable Probe Cover Accessories

ADVANCE MEDICAL DESIGNS, INC.

Medical equipment handle cover, single-use, sterile

• Primary Device ID: 10848340016964
• NIH Device Record Key: 68390c5a-1026-4841-82ff-101fa82a85bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultrasound Probe Cover Biopsy Needle Guide Kit
• Version Model Number: 28-GG305
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848340016967 [Primary]
GS1	10848340016964 [Package]; Contains: 00848340016967; 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

[10848340016964]

Ethylene Oxide

[10848340016964]

Ethylene Oxide

[10848340016964]

Ethylene Oxide

[10848340016964]

Ethylene Oxide

[10848340016964]

Ethylene Oxide

[10848340016964]

Ethylene Oxide

[10848340016964]

Ethylene Oxide

[10848340016964]

Ethylene Oxide

[10848340016964]

Ethylene Oxide

[10848340016964]

Ethylene Oxide

[10848340016964]

Ethylene Oxide

[10848340016964]

Ethylene Oxide

[10848340016964]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-24
• Device Publish Date: 2022-08-16

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