FDA.reportPublic FDA data

Alleset

Primary DI
26931918189946
Brand
Alleset
Company
GRI Medical & Electronic Technology Co., Ltd.
Model
IGS001
Device description
T&A 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
OGREar, Nose, And Throat Surgical Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGREar, Nose, And Throat Surgical TrayEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26931918189946PackageGS16In Commercial Distribution
16931918189949PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2693191818994626931918189946
1693191818994916931918189949

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
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
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10198956583504CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-25
10198956587465CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-25
10198956588967CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-25
10809160538920HALYARDAVID MEDICAL, INC.OGR2026-09-24
10198956350434CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956552272CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956566781CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956566798CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956568631CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956579699CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956582286CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956582989CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956584068CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956584648CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956585379CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-22
10198956521285CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-21
10198956547476CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-21
10198956547902CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-21
10198956555945CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-21
10198956556973CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-21
10198956558809CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-21
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10198956579248CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-21
10198956582859CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-21
B098AMS12206A0Aligned Medical SolutionsAligned Medical SolutionsOGR2026-09-18
10198956463394CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956503397CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04