FDA.reportPublic FDA data

Alleset

Primary DI
16942748430514
Brand
Alleset
Company
GRI Medical & Electronic Technology Co., Ltd.
Model
CP01020070CA01A
Device description
Cataract / Bergen Passaic Laser Center / 01020070_Sterile_10EA/CS
Published
2026-10-15
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
PZGSurgical Eye Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZGSurgical Eye TrayOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26942748430511PackageGS18In Commercial Distribution
16942748430514PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2694274843051126942748430511
1694274843051416942748430514

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.

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
16931918196756AllesetV91-6120-S12026-10-15
16942748412121AllesetV91-6122-S12026-10-15
16942748480953AllesetV91-6132-S12026-10-15
16942748475843AllesetVM-CS0912026-09-08
16931918113425AllesetS90-35302026-09-29
16931918122397Alleset15-0700CW2026-09-29
16931918143040AllesetS90-3020-S22026-09-29
16931918143217AllesetS90-30202026-09-29
16931918143248Alleset90-8030-S12026-09-29
16931918153704AllesetS90-35202026-09-29
16931918155159AllesetS90-3030-S22026-09-29
16931918176680Alleset15-0500-C-HK2026-09-29
16931918182988AllesetS90-3530-S22026-09-29
16931918191614Alleset15-0952HK-WH2026-09-29
16931918192208AllesetV91-6130-S22026-09-29
16931918195544AllesetS90-3520-S22026-09-29
16931918198286AllesetS90-30302026-09-29
16931918199627Alleset80-09135G-S-CL2026-09-29
16931918100852Alleset80-08159-HB2026-07-28
16931918101774Alleset80-08158-HB2026-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05056785304678Enucleation Kit - Vision GiftBLINK MEDICAL LIMITEDPZG2026-09-25
05056785304555Cannula Kit 1 - San JoseBLINK MEDICAL LIMITEDPZG2026-07-31
16931918180090InvenioGRI Medical & Electronic Technology Co., Ltd.PZG2026-07-28
05404027449708Accord SetHasa OptixPZG2026-07-16
05056785303657CANNULA KIT 1 - KAISER PERMANENTE MARTINEZBLINK MEDICAL LIMITEDPZG2026-05-12
05056785303633Cataract Inst Set - Spokane AndersonBLINK MEDICAL LIMITEDPZG2026-05-06
16931918100166InvenioGRI Medical & Electronic Technology Co., Ltd.PZG2026-04-10
16931918103310InvenioGRI Medical & Electronic Technology Co., Ltd.PZG2026-04-10
16931918105574InvenioGRI Medical & Electronic Technology Co., Ltd.PZG2026-04-10
00841668123331KATENAKATENA PRODUCTS, INC.PZG2026-03-02
10841668123338KATENAKATENA PRODUCTS, INC.PZG2026-03-02
05056785303251Cataract Instrument Pack - UCMBLINK MEDICAL LIMITEDPZG2025-12-11
05056785303268Cataract Instrument Pack - UCMBLINK MEDICAL LIMITEDPZG2025-12-11
05056785303015Cataract Inst Set - Spokane AndersonBLINK MEDICAL LIMITEDPZG2025-11-12
05056785303039Cataract Inst Set - Spokane AdamsBLINK MEDICAL LIMITEDPZG2025-11-12
05056785303022Cataract Inst Set - Spokane AndersonBLINK MEDICAL LIMITEDPZG2025-11-12
05056785303046Cataract Inst Set - Spokane AdamsBLINK MEDICAL LIMITEDPZG2025-11-12
05056785302773Cataract Kit – Oklahoma VABLINK MEDICAL LIMITEDPZG2025-10-10
00845819003138Surgeon's Choice CardOASIS MEDICAL, INC.PZG2025-10-02
05056785302599RC Kit 1BLINK MEDICAL LIMITEDPZG2025-09-18
05056785302605RC Kit 1BLINK MEDICAL LIMITEDPZG2025-09-18
05404027449517The Doctor Clinic SetHasa OptixPZG2025-09-12
05404027449524The Doctor Clinic SetHasa OptixPZG2025-09-12
05056785302520RC Kit 2BLINK MEDICAL LIMITEDPZG2025-09-03
05056785302544Stockton Kit 2BLINK MEDICAL LIMITEDPZG2025-09-03
05056785302575Stockton Kit 1BLINK MEDICAL LIMITEDPZG2025-09-03
05056785302537RC Kit 2BLINK MEDICAL LIMITEDPZG2025-09-03
05056785302568Stockton Kit 2BLINK MEDICAL LIMITEDPZG2025-09-03
05056785302582Stockton Kit 1BLINK MEDICAL LIMITEDPZG2025-09-03
05056785302469Kaiser AMD Instrument SetBLINK MEDICAL LIMITEDPZG2025-08-26