FDA.reportPublic FDA data

Invenio

Primary DI
10840365907081
Brand
Invenio
Company
GRI Medical & Electronic Technology Co., Ltd.
Model
MSDC-014226A
Device description
Dressing Change Pack
Published
2024-02-29
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
OXQDressing Change Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXQDressing Change TrayGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840365907081PackageGS120In Commercial Distribution
00840365907084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084036590708110840365907081
00840365907084008403659070848403659070840840365907084

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
16931918113425AllesetS90-35302026-09-29
16931918122397Alleset15-0700CW2026-09-29
16931918143040AllesetS90-3020-S22026-09-29
16931918143217AllesetS90-30202026-09-29
16931918143248Alleset90-8030-S12026-09-29
16931918153704AllesetS90-35202026-09-29
16931918155159AllesetS90-3030-S22026-09-29
16931918176680Alleset15-0500-C-HK2026-09-29
16931918182988AllesetS90-3530-S22026-09-29
16931918191614Alleset15-0952HK-WH2026-09-29
16931918192208AllesetV91-6130-S22026-09-29
16931918195544AllesetS90-3520-S22026-09-29
16931918198286AllesetS90-30302026-09-29
16931918199627Alleset80-09135G-S-CL2026-09-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956580428CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-29
10198956587120CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-29
10198956566644CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-25
10198956568280CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-25
10198956578357CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-25
10198956581654CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-25
10198956586178CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-25
10198956580268CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-22
10198956562271CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-21
10198956573550CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-21
10198956584426CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-21
10653160394389MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10653160394419MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10653160394525MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10653160394648MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10653160394761MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10653160394891MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10653160394990MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10653160395140MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-09-21
10198956538856CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-04
10198956539617CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-04
10198956556744CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-04
10198956564367CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-09-04
10653160394600MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-08-27
10198956541474CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-08-26
10198956548701CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-08-26