Leap Med

GUDID 10848340016995

Disposable Needle Guide

ADVANCE MEDICAL DESIGNS, INC.

Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use

• Primary Device ID: 10848340016995
• NIH Device Record Key: e047f6ac-b608-4e06-9c7c-1e87fe57d5d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leap Med
• Version Model Number: 28-TPU168
• Company DUNS: 130785884
• Company Name: ADVANCE MEDICAL DESIGNS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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	00848340016998 [Primary]
GS1	10848340016995 [Package]; Contains: 00848340016998; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• GDF: GUIDE, NEEDLE, SURGICAL

Sterilization

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

[10848340016995]

Ethylene Oxide

[10848340016995]

Ethylene Oxide

[10848340016995]

Ethylene Oxide

[10848340016995]

Ethylene Oxide

[10848340016995]

Ethylene Oxide

[10848340016995]

Ethylene Oxide

[10848340016995]

Ethylene Oxide

[10848340016995]

Ethylene Oxide

[10848340016995]

Ethylene Oxide

[10848340016995]

Ethylene Oxide

[10848340016995]

Ethylene Oxide

[10848340016995]

Ethylene Oxide

[10848340016995]

Ethylene Oxide

[10848340016995]

Ethylene Oxide

[10848340016995]

Ethylene Oxide

[10848340016995]

Ethylene Oxide

[10848340016995]

Ethylene Oxide

[10848340016995]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-10
• Device Publish Date: 2024-04-02

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• 10848340016995: Disposable Needle Guide
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• 10848340017008: Disposable Needle Guide