FDA.reportPublic FDA data

Invenio

Primary DI
26931918174898
Brand
Invenio
Company
GRI Medical & Electronic Technology Co., Ltd.
Model
LGH017
Device description
Knee Arthro Set-up Pack_Sterile_6EA/CS
Published
2023-10-20
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
OJHOrthopedic Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26931918174898PackageGS16In Commercial Distribution
16931918174891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2693191817489826931918174898
1693191817489116931918174891

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
26931918108718AllesetAGH1X5002026-03-16
06931918122109Alleset15-0500-C2026-02-13
26931918173501Invenioi80-11114G-S2026-02-13
26931918101047AllesetSM5052026-02-09
26931918108411AllesetSM4042026-02-09
26931918139798Alleset99-UPSE2436-N2026-02-09
26931918152353AllesetSM3032026-02-09
26931918161324AllesetSM1012026-02-09
26931918171170AllesetMV-0796EV-S2026-02-09
26931918172931AllesetSM2022026-02-09
26931918141807Alleset44-0796PV-VE-S12026-02-05
26931918105694InvenioGOL0602026-01-21
16931918108155Alleset41-54542026-01-21
26931918125968AllesetCS-6512026-01-21
26931918143498AllesetCS-6502026-01-21
06931918157019Alleset30-015142026-01-21
16931918174334Alleset70-501322026-01-21
26931918184279AllesetCS-6522026-01-21
06931918102354Alleset25-0005-BL-C2025-12-16
26931918171255AllesetC-2015-NS2025-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160521830HalyardAVID MEDICAL, INC.LRO2026-05-26
10198956056497CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956221161CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956253773CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956257610CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956291812CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956321632CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956325487CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956328457CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956348189CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956354517CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956358904CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956369955CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956379190CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956379381CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956380127CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956382763CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956383647CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956387287CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956387492CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956387799CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956388406CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956392465CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956399464CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956400818CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956401136CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956404151CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956413757CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25
10198956414891CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956416802CARDINAL HEALTHCardinal Health 200, LLCLRO2026-05-25