FDA.reportPublic FDA data

Alleset

Primary DI
26931918165155
Brand
Alleset
Company
GRI Medical & Electronic Technology Co., Ltd.
Model
IPS048
Device description
Endovenous Value Pack_Sterile_6ea/cs
Published
2024-09-05
Public version status
Update
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
OEZCardiovascular Procedure Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26931918165155PackageGS16In Commercial Distribution
16931918165158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2693191816515526931918165155
1693191816515816931918165158

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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956418424CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956421479CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956439870CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956462182CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956480834CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956483408CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956485662CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956488861CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
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10198956492080CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956492332CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956496415CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956502420CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
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10198956503915CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
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10198956504325CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956507104CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956511057CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956512603CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956514331CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956517639CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956518391CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09