FDA.reportPublic FDA data

EMSS

Primary DI
06974737270064
Brand
EMSS
Company
SHANGHAI EMSS MED&TECH CO.,LTD.
Model
EG-006
Published
2022-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MRIOrthosis, Truncal/Orthosis, Limb

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRIOrthosis, Truncal/Orthosis, LimbPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974737270064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974737270064069747372700646974737270064

GMDN Terms#

Term, Definition table
TermDefinition
Spine boardA flat, stiff device intended to be placed under a patient (the patient is usually strapped to this device) to ensure spinal immobilization when a spinal injury is suspected. This device is often used in combination with a head/neck immobilizing device that is also typically fixed or strapped to it. It is typically used after serious accidents and for transport of the patient on a stretcher. It is typically made of x-ray translucent/non-ferromagnetically active materials that allow x-ray and magnetic resonance imaging (MRI) and comes in various sizes. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529436952
Device count
1
Premarket exempt
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974737271016EMSSET-0012023-07-19
06974737270125EMSSEG-010B32025-03-12
16974737271013EMSSET-0012023-07-19
06974737278015EMSSEH-0012023-07-18
06974737270101BLARIX/EMSSEG-010A2022-12-21
06974737270118EMSSEG-010B2022-12-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00650551006831ILSO™PMT CORPORATIONMRI2026-07-17
00650551006848ILSO™PMT CORPORATIONMRI2026-07-17
00650551006855ILSO™PMT CORPORATIONMRI2026-07-17
00650551006862ILSO™PMT CORPORATIONMRI2026-07-17
00650551006879ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006886ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006893ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006909ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006916ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006923ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006930ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006947ITLSO™PMT CORPORATIONMRI2026-07-17
00650551006954ILSO™PMT CORPORATIONMRI2026-07-17
00650551006961ITLSO™PMT CORPORATIONMRI2026-07-17
00850040983005WoodyKnowsM&M Pure Air Systems LLCMRI2026-05-19
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00645517890821TrulifeTRULIFE LIMITEDMRI2025-09-11
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00645517899121TrulifeTRULIFE LIMITEDMRI2025-09-11
00645517897776TrulifeTRULIFE LIMITEDMRI2025-08-25
04719879646108ComfyHealthComfy Health Group Co., Ltd.MRI2025-07-10
04719879646115ComfyHealthComfy Health Group Co., Ltd.MRI2025-07-10