Surgi Guard

GUDID 06931918112780

Gown_Standard_Large_Non-Sterile_44ea/cs

GRI Medical & Electronic Technology Co., Ltd.

Surgical gown, single-use

• Primary Device ID: 06931918112780
• NIH Device Record Key: fc2cfff2-6cc9-4f91-9aac-4f30afce6859
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgi Guard
• Version Model Number: SGL
• Company DUNS: 679894738
• Company Name: GRI Medical & Electronic Technology Co., Ltd.
• Device Count: 44
• 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: false
• 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	06931918112780 [Unit of Use]
GS1	16931918112787 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102652

FDA Product Code

• FYA: Gown, Surgical

Sterilization

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

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 [Surgi Guard]

• 06931918171848: Surgical Gown_Raglan Sleeve_W/reinforcement_L_Non-Sterile_36ea/cs
• 06931918161726: Surgical Gown_Raglan Sleeve_W/reinforcement_XL_Non-Sterile_36ea/cs
• 06931918120587: Gown_Standard_XL_Non-Sterile_40ea/cs
• 06931918112780: Gown_Standard_Large_Non-Sterile_44ea/cs