Henry Schein

GUDID 26931918133642

Surgical Gown_Reinforced_SMS_AAMI 3_Raglan Sleeve_One Hand Towel_X-Large_Sterile_22ea/cs

GRI Medical & Electronic Technology Co., Ltd.

Surgical gown, single-use

• Primary Device ID: 26931918133642
• NIH Device Record Key: 01fc4029-cbdc-44a0-8918-924b3c675776
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Henry Schein
• Version Model Number: 570-1670
• Company DUNS: 679894738
• Company Name: GRI Medical & Electronic Technology Co., Ltd.
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com
• Phone: +86057383617385
• Email: link_dong@gri-china.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	16931918133645 [Primary]
GS1	26931918133642 [Package]; Contains: 16931918133645; Package: [22 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102652

FDA Product Code

• FYA: Gown, Surgical

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: 2025-06-30
• Device Publish Date: 2025-06-20

On-Brand Devices [Henry Schein]

• 26931918191529: Isolation gown_Large_35g SMS_Non-sterile_100ea/cs
• 26931918177332: AMMI2 Isolation gown_Large_35g SMS_Non-sterile_100ea/cs
• 26931918172320: AMMI2 Isolation gown_X-Large_35g SMS_Non-sterile_100ea/cs
• 26931918159468: AMMI2 Isolation gown_X-Large_35g SMS_Non-sterile_100ea/cs
• 26931918133307: Isolation gown_X-Large_35g SMS_Non-sterile_100ea/cs
• 26931918125739: AMMI2 Isolation gown_Large_35g SMS_Non-sterile_100ea/cs
• 26931918133642: Surgical Gown_Reinforced_SMS_AAMI 3_Raglan Sleeve_One Hand Towel_X-Large_Sterile_22ea/cs