FDA.reportPublic FDA data

Soule Medical

Primary DI
00810082221374
Brand
Soule Medical
Company
SOULE CO., THE
Model
RUSOPC01
Catalog number
RUSOPC01
Device description
"Universal Strap - One Piece - One Closure - 76"" Length X 2"" Width"
Published
2023-01-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NODBoard, Arm (With Cover), Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NODBoard, Arm (With Cover), Non-SterileGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810082221374PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810082221374008100822213748100822213740810082221374

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.

Regulatory Flags#

DUNS number
032801706
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00081008222502Soule MedicalTP3000NBDSTP3000NBDS2024-04-18
00810082225013Soule MedicalPFC100PFC1002024-04-18
10810082225010Soule MedicalPFC100PFC1002024-04-18
10810082225027Soule MedicalTP3000NBDSTP3000NBDS2024-04-18
00810082221534Soule MedicalRUSOPSRH05RUSOPSRH052023-07-06
00810082221404Soule MedicalRUSOPC04RUSOPC042023-01-20
00810082221411Soule MedicalRUSOPC05RUSOPC052023-01-20
00810082221428Soule MedicalRUSOPC06RUSOPC062023-01-20
00810082221435Soule MedicalRUSOPC07RUSOPC072023-01-20
00810082221442Soule MedicalRUSOPC08RUSOPC082023-01-20
00810082221459Soule MedicalRUSOPC09RUSOPC092023-01-20
00810082221466Soule MedicalRUSOPC10RUSOPC102023-01-20
00810082221473Soule MedicalRUSOPC11RUSOPC112023-01-20
00810082221480Soule MedicalRUSOPC12RUSOPC122023-01-20
00810082221497Soule MedicalRUSOPSRH01RUSOPSRH012023-01-20
00810082221527Soule MedicalRUSOPSRH04RUSOPSRH042023-01-20
00810082221558Soule MedicalRUSOPSRH07RUSOPSRH072023-01-20
00810082220209Soule MedicalRG2150RG21502022-10-12
00810082220216Soule MedicalRG2150-TRG2150-T2022-10-12
00810082220278Soule MedicalRG2175RG21752022-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10840118400661MTIMedical Technology Industries, Inc.NOD2022-12-30
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10840118400692MTIMedical Technology Industries, Inc.NOD2022-12-30
10840118400708MTIMedical Technology Industries, Inc.NOD2022-12-30
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10840118400739MTIMedical Technology Industries, Inc.NOD2022-12-30
10840118400746MTIMedical Technology Industries, Inc.NOD2022-12-30
10840118400753MTIMedical Technology Industries, Inc.NOD2022-12-30
10840118400760MTIMedical Technology Industries, Inc.NOD2022-12-30
10840118400777MTIMedical Technology Industries, Inc.NOD2022-12-30
10840118400784MTIMedical Technology Industries, Inc.NOD2022-12-30
10840118400791MTIMedical Technology Industries, Inc.NOD2022-12-30
10840118400807MTIMedical Technology Industries, Inc.NOD2022-12-30
10840118400814MTIMedical Technology Industries, Inc.NOD2022-12-30
10840118400821MTIMedical Technology Industries, Inc.NOD2022-12-30
10840118400838MTIMedical Technology Industries, Inc.NOD2022-12-30
10840118400845MTIMedical Technology Industries, Inc.NOD2022-12-30
10840118400852MTIMedical Technology Industries, Inc.NOD2022-12-30
10840118400869MTIMedical Technology Industries, Inc.NOD2022-12-30
10840118400876MTIMedical Technology Industries, Inc.NOD2022-12-30
10840118400883MTIMedical Technology Industries, Inc.NOD2022-12-30