FDA.reportPublic FDA data

Invenio

Primary DI
26931918167777
Brand
Invenio
Company
GRI Medical & Electronic Technology Co., Ltd.
Model
LGH026
Device description
Ortho Spine Pack_Sterile_3EA/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
OJGNeurological Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2
OJGNeurological TrayNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26931918167777PackageGS13In Commercial Distribution
16931918167770PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2693191816777726931918167777
1693191816777016931918167770

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
16931918100852Alleset80-08159-HB2026-07-28
16931918101774Alleset80-08158-HB2026-07-28
16931918103037Alleset80-08157-HB2026-07-28
16931918141121AllesetMV-13313-S2026-07-28
16931918145204AllesetMV-13103-S2026-07-28
16931918180090InvenioASI0012026-07-28
16931918183800InvenioMV-13323-S2026-07-28
16931918102214AllesetCS-32092026-07-16
16931918102948AllesetCS-1100HC2026-07-16
16931918107356AllesetCS-32182026-07-16
16931918106694InvenioGOL0292026-06-25
16931918107219InvenioGOL0372026-06-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS14766C0Aligned Medical SolutionsAligned Medical SolutionsOJG2026-09-26
10198459760846MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-09-25
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10198956339729CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956393288CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956461086CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956462205CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956466838CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956497382CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956502604CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956511286CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956513143CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956520608CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956534308CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956541931CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956549357CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956551541CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956552791CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956553910CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956554047CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956558700CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956559752CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956561007CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956561038CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956565425CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956565616CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956565647CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956567788CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956567818CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956568211CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25