Rolled Probe Cover

GUDID 10848340015530

Disposable Equipment Cover

ADVANCE MEDICAL DESIGNS, INC.

Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use

• Primary Device ID: 10848340015530
• NIH Device Record Key: 27ada0d5-a794-405b-a3a7-f57dd49fe843
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rolled Probe Cover
• Version Model Number: 29-PCS2821
• 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	00848340015533 [Primary]
GS1	10848340015530 [Package]; Contains: 00848340015533; Package: [50 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

[10848340015530]

Ethylene Oxide

[10848340015530]

Ethylene Oxide

[10848340015530]

Ethylene Oxide

[10848340015530]

Ethylene Oxide

[10848340015530]

Ethylene Oxide

[10848340015530]

Ethylene Oxide

[10848340015530]

Ethylene Oxide

[10848340015530]

Ethylene Oxide

[10848340015530]

Ethylene Oxide

[10848340015530]

Ethylene Oxide

[10848340015530]

Ethylene Oxide

[10848340015530]

Ethylene Oxide

[10848340015530]

Ethylene Oxide

[10848340015530]

Ethylene Oxide

[10848340015530]

Ethylene Oxide

[10848340015530]

Ethylene Oxide

[10848340015530]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-24
• Device Publish Date: 2024-04-16

On-Brand Devices [Rolled Probe Cover]

• 10848340015547: Disposable Equipment Cover
• 10848340016858: Disposable Equipment Cover
• 10848340016834: Disposable Equipment Cover
• 10848340015530: Disposable Equipment Cover