FDA.reportPublic FDA data

Invenio

Primary DI
26931918190287
Brand
Invenio
Company
GRI Medical & Electronic Technology Co., Ltd.
Model
WHS001
Device description
Breast Hernia Pack _Sterile_4EA/CS
Published
2023-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LROGeneral Surgery Tray
PXIThoracentesis Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2
PXIThoracentesis TrayGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26931918190287PackageGS14In Commercial Distribution
16931918190280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2693191819028726931918190287
1693191819028016931918190280

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
679894738
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
10809160540862HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540886HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540916HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540923HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540930HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540947HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540954HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540961HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540978HalyardAVID MEDICAL, INC.LRO2026-10-20
10809160540985HalyardAVID MEDICAL, INC.LRO2026-10-20
00748426262069Medline-MicrotekMicrotek Medical LLCLRO2026-10-19
10198956377967CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956384774CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956499270CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956499980CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956519527CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956542457CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956544147CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956567627CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956568495CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956568501CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956569300CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956572607CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956581173CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956581234CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956583016CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956583702CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956583900CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956583979CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19
10198956583993CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-19