FDA.reportPublic FDA data

Alleset

Primary DI
06931918171060
Brand
Alleset
Company
GRI Medical & Electronic Technology Co., Ltd.
Model
30-10055
Device description
Needle Counter_Red_10-Count_2ea Magnet_foam block_N/S_64ea/cs
Published
2023-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GABNeedle, Suturing, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GABNeedle, Suturing, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16931918171067PrimaryGS10
06931918171060Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693191817106716931918171067
06931918171060069319181710606931918171060

GMDN Terms#

Term, Definition table
TermDefinition
Sharp surgical instrument counting tray/pad, single-useA device intended to be used in the operating room (OR) by staff to maintain the count of various sharp surgical instruments (e.g., needles, blades, scissors) to prevent instruments from being inadvertently left in a patient; it may in addition be used for temporary storage of instruments during surgery. The counter is usually flat when in use and employs magnetism, foam rubber, or some other mechanism to hold the counted objects in place. 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
64
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
false
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
26931918108718AllesetAGH1X5002026-03-16
06931918122109Alleset15-0500-C2026-02-13
26931918173501Invenioi80-11114G-S2026-02-13
26931918101047AllesetSM5052026-02-09
26931918108411AllesetSM4042026-02-09
26931918139798Alleset99-UPSE2436-N2026-02-09
26931918152353AllesetSM3032026-02-09
26931918161324AllesetSM1012026-02-09
26931918171170AllesetMV-0796EV-S2026-02-09
26931918172931AllesetSM2022026-02-09
26931918141807Alleset44-0796PV-VE-S12026-02-05
26931918105694InvenioGOL0602026-01-21
16931918108155Alleset41-54542026-01-21
26931918125968AllesetCS-6512026-01-21
26931918143498AllesetCS-6502026-01-21
06931918157019Alleset30-015142026-01-21
16931918174334Alleset70-501322026-01-21
26931918184279AllesetCS-6522026-01-21
06931918102354Alleset25-0005-BL-C2025-12-16
26931918171255AllesetC-2015-NS2025-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06931918157019AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2026-01-21
07350154050004SutureTOOLSuturion ABGAB2025-12-15
26931918179855AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2025-06-21
06931918144941AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2025-06-20
20192253052326DevonCardinal Health 200, LLCGAB2025-05-29
50192253052136DevonCardinal Health 200, LLCGAB2025-03-27
20192253052142DevonCardinal Health 200, LLCGAB2025-03-27
50192253052150DevonCardinal Health 200, LLCGAB2025-03-27
20192253052166DevonCardinal Health 200, LLCGAB2025-03-27
50192253052174DevonCardinal Health 200, LLCGAB2025-03-27
20192253052180DevonCardinal Health 200, LLCGAB2025-03-27
20192253052197DevonCardinal Health 200, LLCGAB2025-03-27
50192253052204DevonCardinal Health 200, LLCGAB2025-03-27
20192253052210DevonCardinal Health 200, LLCGAB2025-03-27
20192253052227DevonCardinal Health 200, LLCGAB2025-03-27
20192253052234DevonCardinal Health 200, LLCGAB2025-03-27
50192253052242DevonCardinal Health 200, LLCGAB2025-03-27
50192253052259DevonCardinal Health 200, LLCGAB2025-03-27
50192253052266DevonCardinal Health 200, LLCGAB2025-03-27
20192253052272DevonCardinal Health 200, LLCGAB2025-03-27
50192253052280DevonCardinal Health 200, LLCGAB2025-03-27
20192253052296DevonCardinal Health 200, LLCGAB2025-03-27
50192253052310DevonCardinal Health 200, LLCGAB2025-03-27
50192253052334DevonCardinal Health 200, LLCGAB2025-03-27
20192253052340DevonCardinal Health 200, LLCGAB2025-03-27
20192253052357DevonCardinal Health 200, LLCGAB2025-03-27
50192253052365DevonCardinal Health 200, LLCGAB2025-03-27
50192253052372DevonCardinal Health 200, LLCGAB2025-03-27
50192253052389DevonCardinal Health 200, LLCGAB2025-03-27
50192253053355DevonCardinal Health 200, LLCGAB2025-03-27