FDA.reportPublic FDA data

Alleset

Primary DI
16931918142616
Brand
Alleset
Company
GRI Medical & Electronic Technology Co., Ltd.
Model
TUF019
Device description
Arterial Pack_Sterile_2EA/CS
Published
2024-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
26931918142613PackageGS12In Commercial Distribution
16931918142616PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2693191814261326931918142613
1693191814261616931918142616

GMDN Terms#

Term, Definition table
TermDefinition
Non-dedicated vascular surgical procedure kitA collection of various surgical instruments and supportive devices/materials intended to support multiple types of vascular surgical/access procedures (non-dedicated); it is not intended to support a catheterization procedure. It typically includes devices such as syringes, needles, scalpel, swabs, dressings, and drapes; it does not include any pharmaceuticals. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+86057383617385linkdong@gri-china.com

Regulatory Flags#

DUNS number
679894738
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
00884450376867Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-26
00884450431597Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-26
00884450432105Merit Medical®Merit Medical Systems, Inc.OEZ2026-09-26
B098AMS195240Aligned Medical SolutionsAligned Medical SolutionsOEZ2026-09-26
10197106992753CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956169357CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
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10198956466159CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
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10198956529540CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956541566CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956547506CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956553835CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956562035CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956562820CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956570689CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956570863CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956577640CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956578388CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956580145CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956582439CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956583283CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956583320CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956583412CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956583665CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956583726CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956584501CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956584518CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956584839CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25
10198956585201CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-09-25