Surgi Guard

GUDID 06931918120587

Gown_Standard_XL_Non-Sterile_40ea/cs

GRI Medical & Electronic Technology Co., Ltd.

Surgical gown, single-use
Primary Device ID06931918120587
NIH Device Record Key6c4ea71f-d35f-4693-a975-d2a0f766a861
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurgi Guard
Version Model NumberSGXL
Company DUNS679894738
Company NameGRI Medical & Electronic Technology Co., Ltd.
Device Count40
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+86057383617385
Emaillink_dong@gri-china.com
Phone+86057383617385
Emaillink_dong@gri-china.com
Phone+86057383617385
Emaillink_dong@gri-china.com
Phone+86057383617385
Emaillink_dong@gri-china.com
Phone+86057383617385
Emaillink_dong@gri-china.com
Phone+86057383617385
Emaillink_dong@gri-china.com
Phone+86057383617385
Emaillink_dong@gri-china.com
Phone+86057383617385
Emaillink_dong@gri-china.com
Phone+86057383617385
Emaillink_dong@gri-china.com
Phone+86057383617385
Emaillink_dong@gri-china.com
Phone+86057383617385
Emaillink_dong@gri-china.com
Phone+86057383617385
Emaillink_dong@gri-china.com

Device Identifiers

Device Issuing AgencyDevice ID
GS106931918120587 [Unit of Use]
GS116931918120584 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FYAGown, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-30
Device Publish Date2025-06-20

On-Brand Devices [Surgi Guard]

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

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