FDA.reportPublic FDA data

Invenio

Primary DI
26931918173617
Brand
Invenio
Company
GRI Medical & Electronic Technology Co., Ltd.
Model
SUM007
Device description
ACL Reconstruction Pack_Sterile_3EA/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
OJHOrthopedic Tray
PPQTranstibial Anterior Cruciate Ligament Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1
PPQTranstibial Anterior Cruciate Ligament KitOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26931918173617PackageGS13In Commercial Distribution
16931918173610PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2693191817361726931918173617
1693191817361016931918173610

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
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10198956483835CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956484719CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956484764CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956484887CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956487192CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956488175CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08