FDA.reportPublic FDA data

Alleset

Primary DI
16931918199863
Brand
Alleset
Company
GRI Medical & Electronic Technology Co., Ltd.
Model
Model PSC1616-3-COVER
Device description
Optimum Pommel Cushion_POM_16inx16inx3in_50ea/cs
Published
2021-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IMPCUSHION, WHEELCHAIR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMPCushion, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16931918199863PrimaryGS10
06931918199866Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693191819986316931918199863
06931918199866069319181998666931918199866

GMDN Terms#

Term, Definition table
TermDefinition
Medical cushion coverA device intended to cover a medical cushion (e.g., birthing cushion, lumbar cushion, wheelchair cushion) during use to protect the cushion from dirt/debris to maintain hygiene. It may be dedicated to a specific type of cushion or non-dedicated; it is not intended for surgical use and is not intended to cover a pillow primarily used in bed. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+86057383617385link_dong@gri-metc.com

Regulatory Flags#

DUNS number
679894738
Device count
50
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16931918145563Alleseti90-4230-HB2025-11-11
16931918170893Alleset10-0282026-05-08
16931918118994Beaver Visitec Inter603004652022-12-06
16931918122182Invenioi91-61422024-02-12
16931918122380Invenioi91-4320-S12024-02-02
16931918123714Invenioi91-61302024-02-02
16931918124056Invenioi91-4330-S12024-02-02
16931918127064Invenioi90-7032-S12024-02-02
16931918128573Invenioi90-80002022-12-06
16931918129006Invenioi91-4330-HB2024-02-02
16931918129631Invenioi90-80322024-02-17
16931918134277Invenioi91-12422024-02-12
16931918137407Beaver Visitec Inter603004552022-12-05
16931918140926Invenioi90-4220-W1-HB2024-02-17
16931918140995Invenioi91-4320-HB2024-02-12
16931918142562Invenioi91-61242024-02-12
16931918142661Invenioi91-61202024-02-02
16931918143163Invenioi91-6130-W12024-02-12
16931918144641Invenioi91-1230-W1-HB2024-02-12
16931918145457Invenioi91-6130-S12024-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196312276MEDLINEMEDLINE INDUSTRIES, INC.IMP2026-02-04
09420082696471Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696488Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696495Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696501Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696518Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696525Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696532Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696549Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696556Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696563Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696570Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696587Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696594Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696600Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696617Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696624Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696631Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696648Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696655Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696662Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696679Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696686Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696693Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696709Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696716Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696723Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696730Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696747Spex LimitedSPEX LIMITEDIMP2025-11-07
09420082696754Spex LimitedSPEX LIMITEDIMP2025-11-07