Ultrasound Probe Cover Biopsy Needle Guide Kit

GUDID 10848340017404

Disposable Probe Cover Accessories

ADVANCE MEDICAL DESIGNS, INC.

Medical equipment handle cover, single-use, sterile

• Primary Device ID: 10848340017404
• NIH Device Record Key: 196f7c7e-891d-4eac-b21a-ff468b6cb18d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultrasound Probe Cover Biopsy Needle Guide Kit
• Version Model Number: 28-EG131
• 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	00848340017407 [Primary]
GS1	10848340017404 [Package]; Contains: 00848340017407; 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

[10848340017404]

Ethylene Oxide

[10848340017404]

Ethylene Oxide

[10848340017404]

Ethylene Oxide

[10848340017404]

Ethylene Oxide

[10848340017404]

Ethylene Oxide

[10848340017404]

Ethylene Oxide

[10848340017404]

Ethylene Oxide

[10848340017404]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-11
• Device Publish Date: 2022-07-01

On-Brand Devices [Ultrasound Probe Cover Biopsy Needle Guide Kit]

• 10848340015264: Disposable Probe Cover Accessories
• 10848340017336: Disposable Probe Cover Accessories
• 10848340017329: Disposable Probe Cover Accessories
• 10848340017305: Disposable Probe Cover Accessories
• 10848340017343: Disposable Probe Cover Accessories
• 10848340017602: Disposable Probe Cover Accessories
• 10848340017367: Disposable Probe Cover Accessories
• 10848340017350: Disposable Probe Cover Accessories
• 10848340018524: Disposable Probe Cover Accessories
• 10848340017619: Disposable Probe Cover Accessories
• 10848340017381: Disposable Probe Cover Accessories
• 10848340017374: Disposable Probe Cover Accessories
• 10848340017428: Disposable Probe Cover Accessories
• 10848340017411: Disposable Probe Cover Accessories
• 10848340017404: Disposable Probe Cover Accessories
• 10848340017398: Disposable Probe Cover Accessories
• 10848340018357: Disposable Probe Cover Accessories
• 10848340017435: Disposable Probe Cover Accessories
• 10848340017459: Disposable Probe Cover Accessories
• 10848340017442: Disposable Probe Cover Accessories
• 10848340017503: Disposable Probe Cover Accessories
• 10848340017497: Disposable Probe Cover Accessories
• 10848340017480: Disposable Probe Cover Accessories
• 10848340017473: Disposable Probe Cover Accessories
• 10848340017466: Disposable Probe Cover Accessories
• 10848340017534: Disposable Probe Cover Accessories
• 10848340017527: Disposable Probe Cover Accessories
• 10848340017510: Disposable Probe Cover Accessories
• 10848340017596: Disposable Probe Cover Accessories
• 10848340017589: Disposable Probe Cover Accessories
• 10848340017572: Disposable Probe Cover Accessories
• 10848340017565: Disposable Probe Cover Accessories
• 10848340017558: Disposable Probe Cover Accessories
• 10848340017541: Disposable Probe Cover Accessories
• 10848340016940: Disposable Probe Cover Accessories
• 10848340016971: Disposable Probe Cover Accessories
• 10848340016964: Disposable Probe Cover Accessories
• 10848340016957: Disposable Probe Cover Accessories
• 10848340015288: Disposable Probe Cover Accessories
• 10848340015271: Disposable Probe Cover Accessories
• 10848340015325: Disposable Probe Cover Accessories
• 10848340015301: Disposable Probe Cover Accessories
• 10848340015295: Disposable Probe Cover Accessories
• 10848340015356: Disposable Probe Cover Accessories
• 10848340015349: Disposable Probe Cover Accessories
• 10848340015332: Disposable Probe Cover Accessories
• 10848340015318: Disposable Probe Cover Accessories
• 10848340013857: Disposable Probe Cover Accessories
• 10848340015394: Disposable Probe Cover Accessories
• 10848340015387: Disposable Probe Cover Accessories