FDA.reportPublic FDA data

Invenio

Primary DI
26931918185306
Brand
Invenio
Company
GRI Medical & Electronic Technology Co., Ltd.
Model
TUF006
Device description
CABG Supplemental Pack_Sterile_20EA/CS
Published
2024-04-26
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
OEZCardiovascular Procedure Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26931918185306PackageGS120In Commercial Distribution
16931918185309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2693191818530626931918185306
1693191818530916931918185309

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
16931918100876Alleset80-01306T2026-06-04
16931918102450Alleset001-CAM0796PS2026-06-04
16931918104201Alleset001-BND0022S2026-06-04
16931918104416Alleset001-BND3636S2026-06-04
16931918104645Alleset80-01305T2026-06-04
16931918104843Alleset001-CARM24S2026-06-04
16931918104935Alleset001-BND3020S2026-06-04
16931918105239Alleset001-BND0018S2026-06-04
16931918106977Alleset001-CARM9S2026-06-04
16931918107400Alleset001-BND3620S2026-06-04
16931918107929Alleset001-CAM0796EVS2026-06-04
16931918108261Alleset001-BND0014S2026-06-04
16931918109640Alleset001-CAM0996ES2026-06-04
16931918109855Alleset001-CAM0796ES2026-06-04
16931918109879Alleset001-BND3630S2026-06-04
16931918117102Alleset001-BND3640S2026-06-04
16931918119823Alleset50-LFT0012026-06-04
16931918123325Alleset90-8030ST2026-06-04
16931918139449Alleset001-CARM2S2026-06-04
16931918179179Alleset80-01304T2026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450079973Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-09
00884450101537Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-09
00884450101568Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-09
00884450486962Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-09
10809160523063HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523070HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523094HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523100HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523124HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523131HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523162HalyardAVID MEDICAL, INC.OEZ2026-06-09
10809160523179HalyardAVID MEDICAL, INC.OEZ2026-06-09
10809160523186HalyardAVID MEDICAL, INC.OEZ2026-06-09
10809160523209HalyardAVID MEDICAL, INC.OEZ2026-06-09
10809160523216HalyardAVID MEDICAL, INC.OEZ2026-06-09
10809160523223HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523230HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523247HalyardAVID MEDICAL, INC.LRO2026-06-09
10197106911266CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956182264CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956359024CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956364783CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956394766CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956429666CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956432048CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956433144CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956443518CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956444454CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-08
10198956466012CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956467484CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08