FDA.reportPublic FDA data

Alleset

Primary DI
26931918177547
Brand
Alleset
Company
GRI Medical & Electronic Technology Co., Ltd.
Model
Model 50-150201
Device description
Ulnar Nerve Protectors_15.5 x 6 x2in (39 x 15 x 5cm)_36EA/CS
Published
2021-02-09
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
FMQRestraint, protective

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMQRestraint, ProtectiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26931918177547PackageGS136In Commercial Distribution
16931918177540PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2693191817754726931918177547
1693191817754016931918177540

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding patient positioner, single-useA preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+86057383617385link_dong@gri-metc.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
false
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
00748426263943Medline-MicrotekMicrotek Medical LLCFMQ2026-01-21
20884389198749MEDLINEMEDLINE INDUSTRIES, INC.FMQ2025-11-14
10190676008299PoseyPOSEY PRODUCTS, LLCFMQ2025-07-16
00749756399173DeRoyalDEROYAL INDUSTRIES, INC.FMQ2025-06-19
10810178883117ViveVIVE HEALTH LLCFMQ2025-05-19
10815614021115Elevate ArmBoard Extender HSemler Technologies, Inc.FMQ2025-05-19
10815614021122Elevate ArmBoard Extender H Semler Technologies, Inc.FMQ2025-05-19
00748426141128Medline-MicrotekMicrotek Medical LLCFMQ2025-04-08
06974737270125EMSSSHANGHAI EMSS MED&TECH CO.,LTD.FMQ2025-03-12
10815614021092mBrace 4285 Wrist Support with HookSemler Technologies, Inc.FMQ2025-02-27
00195278925428Pristina PaddleGE MEDICAL SYSTEMSFMQ2025-01-09
10888277673472MEDLINEMEDLINE INDUSTRIES, INC.FMQ2025-01-04
10197344112937MEDLINEMEDLINE INDUSTRIES, INC.FMQ2024-11-29
10197344112944MEDLINEMEDLINE INDUSTRIES, INC.FMQ2024-11-29
10197344112258MEDLINEMEDLINE INDUSTRIES, INC.FMQ2024-11-14
10888277699557MEDLINEMEDLINE INDUSTRIES, INC.FMQ2024-08-07
09010279001050iFIXiSYS Medizintechnik GmbHFMQ2024-07-30
09010279001289iFIXiSYS Medizintechnik GmbHFMQ2024-07-30
29010279001702iFIXiSYS Medizintechnik GmbHFMQ2024-07-30
29010279001719iFIXiSYS Medizintechnik GmbHFMQ2024-07-30
10810113577484ViveVIVE HEALTH LLCFMQ2024-07-17
00749756394567DeRoyalDEROYAL INDUSTRIES, INC.FMQ2024-07-03
00749756394574DeRoyalDEROYAL INDUSTRIES, INC.FMQ2024-07-03
00749756394581DeRoyalDEROYAL INDUSTRIES, INC.FMQ2024-07-03
00749756394598DeRoyalDEROYAL INDUSTRIES, INC.FMQ2024-07-03
00749756394604DeRoyalDEROYAL INDUSTRIES, INC.FMQ2024-07-03
00749756394611DeRoyalDEROYAL INDUSTRIES, INC.FMQ2024-07-03
06931918129979HALYARDGRI Medical & Electronic Technology Co., Ltd.FMQ2024-06-11
06931918189829HALYARDGRI Medical & Electronic Technology Co., Ltd.FMQ2024-06-11
50080196281372MedlineMEDLINE INDUSTRIES, INC.FMQ2024-05-01