Alleset00000

GUDID 26931918126910

Surgical Gown_Set-In sleeve_Standard_Large_Extra Long_W/ one hand towel_Sterile_28ea/cs

GRI Medical & Electronic Technology Co., Ltd.

Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use Surgical gown, single-use

• Primary Device ID: 26931918126910
• NIH Device Record Key: 47bd33bb-1993-4258-92d5-3892d59fd9db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alleset00000
• Version Model Number: SF90-8022-S1
• 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
• 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	16931918126913 [Primary]
GS1	26931918126910 [Package]; Contains: 16931918126913; Package: [28 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: 2023-07-28
• Device Publish Date: 2023-07-20

Devices Manufactured by GRI Medical & Electronic Technology Co., Ltd.

• 26931918100064 - Alleset: 2024-05-20 gentleheel_for_newborn_ETO_500ea/cs
• 26931918115778 - Invenio: 2024-05-06 EXTREMITY PACK_Sterile_3EA/CS
• 26931918121342 - Invenio: 2024-05-06 Kypho Pack_Sterile_6EA/CS
• 06931918121379 - Invenio: 2024-05-06 Surgical Gown_i600_Film Reinforced_XL_Non-Sterile_324ea/cs
• 26931918122851 - Syndeo Medical: 2024-05-06 Pacemaker Pack_Sterile_6EA/CS
• 06931918126206 - Invenio: 2024-05-06 Impervious Interventional Femoral Angiography Drape_W/ windows_W/side panel_87inx135in_NS_100ea/cs
• 26931918126484 - Invenio: 2024-05-06 Pacemaker Pack_Sterile_6EA/CS
• 26931918126743 - Alleset: 2024-05-06 Pediatric_Laparotomy_Drape_76inx122in_sterile_13ea/cs