ARMADA NOT 6/10

GUDID 10812261012602

ARMADA Nottingham One Step Dilator 6F/10F

ALLWIN MEDICAL DEVICES, INC.

Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use Endoscopic-access dilator, single-use

• Primary Device ID: 10812261012602
• NIH Device Record Key: 9df158f9-26d0-4199-90e0-526721015a97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARMADA
• Version Model Number: ARMADA Nottingham One Step Dilator 6F/10F
• Catalog Number: NOT 6/10
• Company DUNS: 796354509
• Company Name: ALLWIN MEDICAL DEVICES, INC.
• Device Count: 1
• DM Exempt: false
• 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: true
• 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

Customer Support Contacts

• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com
• Phone: 714-572-1709
• Email: info@allwinmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812261012605 [Primary]
GS1	10812261012602 [Package]; Contains: 00812261012605; Package: Box Packing [10 Units]; In Commercial Distribution

FDA Product Code

• EZN: Dilator, Catheter, Ureteral

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-08
• Device Publish Date: 2023-07-31

On-Brand Devices [ARMADA]

• 10812261012619: ARMADA Nottingham One Step Dilator 6F/12F
• 10812261012602: ARMADA Nottingham One Step Dilator 6F/10F