FDA.reportPublic FDA data

Invenio

Primary DI
16931918169255
Brand
Invenio
Company
GRI Medical & Electronic Technology Co., Ltd.
Model
TWC001
Device description
Cysto Pack_6EA/CS
Published
2023-10-27
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
PPFUrinary Irrigation Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPFUrinary Irrigation KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26931918169252PackageGS16In Commercial Distribution
16931918169255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2693191816925226931918169252
1693191816925516931918169255

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.

Contacts#

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

Regulatory Flags#

DUNS number
679894738
Device count
1
Premarket exempt
true
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
16931918145563Alleseti90-4230-HB2025-11-11
16931918170893Alleset10-0282026-05-08
16931918118994Beaver Visitec Inter603004652022-12-06
16931918122182Invenioi91-61422024-02-12
16931918122380Invenioi91-4320-S12024-02-02
16931918123714Invenioi91-61302024-02-02
16931918124056Invenioi91-4330-S12024-02-02
16931918127064Invenioi90-7032-S12024-02-02
16931918128573Invenioi90-80002022-12-06
16931918129006Invenioi91-4330-HB2024-02-02
16931918129631Invenioi90-80322024-02-17
16931918134277Invenioi91-12422024-02-12
16931918137407Beaver Visitec Inter603004552022-12-05
16931918140926Invenioi90-4220-W1-HB2024-02-17
16931918140995Invenioi91-4320-HB2024-02-12
16931918142562Invenioi91-61242024-02-12
16931918142661Invenioi91-61202024-02-02
16931918143163Invenioi91-6130-W12024-02-12
16931918144641Invenioi91-1230-W1-HB2024-02-12
16931918145457Invenioi91-6130-S12024-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918158259InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-04-26
16931918129235InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
16931918133737InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
16931918154916InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
16931918159546InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
16931918166513InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
16931918186344InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
16931918189604InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
16931918196305InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
26931918129232InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
26931918133734InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
26931918154913InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
26931918159543InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
26931918166510InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
26931918186341InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
26931918189601InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
26931918196302InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
16931918133799InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-02
16931918139814InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-02
16931918144603InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-02
16931918186696InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-02
26931918133796InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-02
26931918139811InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-02
26931918144600InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-02
26931918186693InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-02
16931918124025InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2023-10-27
26931918124022InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2023-10-27
26931918169252InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2023-10-27
16931918149646InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2023-10-20
16931918151861InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2023-10-20