FDA.reportPublic FDA data

Invenio

Primary DI
16931918191355
Brand
Invenio
Company
GRI Medical & Electronic Technology Co., Ltd.
Model
i90-8000-S1
Device description
Surgical Gown_Set-In sleeve_Standard_Small_W/ one hand towel_Sterile_22ea/cs
Published
2024-02-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FYAGown, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYAGown, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162442000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162442000ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500Gri Medical & Electrical Technology Co., Ltd.2016-12-12FYA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26931918191352PackageGS122In Commercial Distribution
16931918191355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2693191819135226931918191352
1693191819135516931918191355

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gown, single-useA garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.

Contacts#

Phone, Email table
PhoneEmail
+86057383617385link_dong@gri-china.com

Regulatory Flags#

DUNS number
679894738
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16931918196756AllesetV91-6120-S12026-10-15
16942748412121AllesetV91-6122-S12026-10-15
16942748430514AllesetCP01020070CA01A2026-10-15
16942748480953AllesetV91-6132-S12026-10-15
16942748475843AllesetVM-CS0912026-09-08
16931918113425AllesetS90-35302026-09-29
16931918122397Alleset15-0700CW2026-09-29
16931918143040AllesetS90-3020-S22026-09-29
16931918143217AllesetS90-30202026-09-29
16931918143248Alleset90-8030-S12026-09-29
16931918153704AllesetS90-35202026-09-29
16931918155159AllesetS90-3030-S22026-09-29
16931918176680Alleset15-0500-C-HK2026-09-29
16931918182988AllesetS90-3530-S22026-09-29
16931918191614Alleset15-0952HK-WH2026-09-29
16931918192208AllesetV91-6130-S22026-09-29
16931918195544AllesetS90-3520-S22026-09-29
16931918198286AllesetS90-30302026-09-29
16931918199627Alleset80-09135G-S-CL2026-09-29
16931918100852Alleset80-08159-HB2026-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918196756AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-10-15
16942748412121AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-10-15
16942748480953AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-10-15
00627755521002Lac-MacLac-Mac LimitedFYA2026-10-13
16931918113425AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918143040AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918143217AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918143248AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918153704AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918155159AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918182988AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918192208AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918195544AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918198286AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
04719882251900CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-07-31
04719882251924CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-07-31
04719882251948CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-07-31
04719882251962CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-07-31
09009607835207ViVi® PEEL-OFF TOGA PREMIUM XL-XXLTHI Total Healthcare Innovation GmbHFYA2026-07-22
09009607835214ViVi® PEEL-OFF TOGA PREMIUM M-LTHI Total Healthcare Innovation GmbHFYA2026-07-22
09009607835221ViVi® PEEL-OFF TOGA PREMIUM XXS-STHI Total Healthcare Innovation GmbHFYA2026-07-22
09009607835238ViVi® PEEL-OFF TOGA PREMIUM 3XLTHI Total Healthcare Innovation GmbHFYA2026-07-22
10193489135909MEDLINEMEDLINE INDUSTRIES, INC.FYA2026-07-17
04719882251887CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-06-25
50885380134560CARDINAL HEALTHCardinal Health 200, LLCFYA2026-06-24
16931918123325AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-06-04
08809518442430SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442447SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442454SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442461SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07