FDA.report

Invenio

Primary DI
10840365904264
Brand
Invenio
Company
Gri-Alleset, Inc.
Model
IDN001
Device description
Cath Pack
Published
2023-09-08
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

Related Records

Contact Domains

Product Codes

CodeName
LROGeneral Surgery Tray

Product Code Classifications

CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10840365904264PackageGS16In Commercial Distribution
00840365904267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084036590426410840365904264
00840365904267008403659042678403659042670840365904267

GMDN Terms

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

Contacts

PhoneEmail
+86057383617385link_dong@gri-china.com

Regulatory Flags

DUNS number
015356845
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 DIBrandModelCatalogPublished
10840365905636InvenioBUA0072023-09-15
10840365905650InvenioGOL0032023-09-15
10840365905681InvenioDMC0012023-09-15
10840365905711InvenioIBJ0022023-09-15
10840365905728InvenioMVI0022023-09-15
10840365905735InvenioHMH0112023-09-15
10840365905766InvenioAOS0052023-09-15
10840365906053InvenioBTI0042023-09-15
10840365906077InvenioLGH0232023-09-15
10840365906084InvenioBUA0102023-09-15
10840365906091InvenioKLE0062023-09-15
10840365906107InvenioLGH0182023-09-15
10840365906176InvenioLEM0022023-09-15
10840365906220InvenioDCI0052023-09-15
10840365906244InvenioCVA0022023-09-15
10840365906268InvenioAOS0012023-09-15
10840365906275InvenioWTF0132023-09-15
10840365906282InvenioASM0022023-09-15
10840365906299InvenioBUA0012023-09-15
10840365906305InvenioCAR0012023-09-15

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