Invenio

GUDID 26931918116195

Surgical Gown_Set-In Sleeve_W/reinforcement_XXL_Invenio Extra Long_W/ 1 hand towel_Sterile_18ea/cs

GRI Medical & Electronic Technology Co., Ltd.

Surgical gown, single-use

• Primary Device ID: 26931918116195
• NIH Device Record Key: 793af1fc-63cb-43d1-9fc4-996a7af7b77f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invenio
• Version Model Number: i90-1242-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	16931918116198 [Primary]
GS1	26931918116195 [Package]; Contains: 16931918116198; Package: [18 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: 2024-02-26
• Device Publish Date: 2024-02-17

On-Brand Devices [Invenio]

• 26931918191215: Cape Cod Core RTK_CCRTK-01_Non sterile_14ea/cs
• 26931918156214: Room Turnaround Kit, Non Sterile
• 26931918151066: Cape Cod Core RTK_CCRTK-03_Non sterile_12ea/cs
• 06931918145429: Special Procedure Drape_38inx55in_Non-Sterile_48EA/CS
• 06931918131415: Femoral Angiography Drape_with Clear Side Window_76inx120in_Non-Sterile_18ea/cs
• 06931918186057: Large Drape_60inx76in_Non-Sterile_24ea/cs
• 06931918173873: Lower Extremity Drape_285cmx223cmx320cm_Sterile_10ea/cs
• 06931918128576: Surgical Gown_Set-In sleeve_Standard_Small_Non-Sterile_32ea/cs
• 26931918116041: Eye Drape_W/ Fluid Pouch_72inx115in_Sterile_14ea/cs
• 26931918181551: TUR Drape_160x217x260cm_Sterile_12ea/cs
• 26931918151943: Surgical Gown_Set-In sleeve_Standard_Medium_W/ one hand towel_Sterile_32ea/cs
• 26931918196203: MINOR PLASTIC PACK_Sterile_4EA/CS
• 26931918177899: Abdominoplasty Pack_Sterile_3EA/CS
• 26931918170746: D & C Pack_Sterile_3EA/CS
• 26931918170692: Neuro Spine Pack_Sterile_2EA/CS
• 26931918167364: ENT Pack_Sterile_2EA/CS
• 26931918163663: STANDARD CYSTOSCOPY PACK_Sterile_4EA/CS
• 26931918149759: Myringotomy Pack_Sterile_10EA/CS
• 26931918149292: ACL Pack_Sterile_4EA/CS
• 26931918138746: Delivery Pack_Sterile_5EA/CS
• 26931918137312: Laparoscopic Pack_3EA/CS
• 26931918199921: Hand Pack_Sterile_3EA/CS
• 26931918198962: Extremity Pack _Sterile_4EA/CS
• 26931918198078: Compression Hip Pack _Sterile_5EA/CS
• 06931918198012: Surgical Gown_Set-In sleeve_Standard_XL_Non-sterile_378ea/cs
• 26931918197569: Head and Neck Pack_Sterile_6EA/CS
• 26931918195992: Knee Arthoscopy Pack_Sterile_4EA/CS
• 26931918195756: Plastic Pack_Sterile_4EA/CS
• 26931918195497: Hand General Pack_6EA/CS
• 26931918195435: Single Wrapped Basin_Sterile_10EA/CS
• 26931918194575: SHOULDER PACK_Sterile_3ea/cs
• 26931918194315: Basic Pack_Sterile_3EA/CS
• 26931918193370: Basic Pack_Sterile_3EA/CS
• 26931918193233: Double Wrapped Basin_Sterile_10EA/CS
• 26931918191826: Myringotomy Pack_Sterile_12EA/CS
• 26931918190973: C-Section Pack _Sterile_2EA/CS
• 26931918190850: ACL Pack_3EA/CS
• 26931918190348: Laminectomy Pack_Sterile_3EA/CS
• 26931918188260: Arthroscopy Pack_Sterile_3EA/CS
• 26931918187805: D&C Pack_2EA/CS
• 26931918185146: General Pack_Sterile_4EA/CS
• 26931918184637: Basic Pack_Sterile_8EA/CS
• 26931918184323: General Breast Pack_Sterile_2EA/CS
• 06931918184213: Surgical Gown_Set-In sleeve_Standard_XL_W/ one hand towel_Non-sterile_378ea/cs
• 26931918184170: PPE PACK_Non-Sterile_72EA/CS
• 26931918183852: Shoulder Scope Pack_4EA/CS
• 26931918183722: PREP PACK_ Sterile_8EA/CS
• 26931918183296: Knee Arthroscopy_Sterile_4EA/CS
• 26931918181544: Hand Pack_Sterile_6EA/CS
• 26931918179589: Carotid Pack _Sterile_4EA/CS