FDA.report

Alleset

Primary DI
26931918172467
Brand
Alleset
Company
GRI Medical & Electronic Technology Co., Ltd.
Model
GWC1616-2
Device description
Gel Wheelchair Cushion_black_16inx16inx2in_4ea/cs
Published
2022-11-23
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

Related Records

Contact Domains

Product Codes

CodeName
IMPCushion, Wheelchair

Product Code Classifications

CodeDeviceSpecialtyClass
IMPCushion, WheelchairPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
26931918172467PackageGS14In Commercial Distribution
16931918172460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2693191817246726931918172467
1693191817246016931918172460

GMDN Terms

TermDefinition
Operating room turnover kitA collection of devices intended to be used to efficiently clean and prepare an operating room (OR) for a subsequent surgical procedure. It typically includes patient oriented items such as absorbent covers/drapes for the operating table and patient positioners (e.g., headrest), operating room cleaning items such as cleaning mop heads and pads, and refuse containment items such as surgical waste and biohazard bags/buckets. This is a single-use device.

Sterilization Methods

Method

Contacts

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
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 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

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