FDA.reportPublic FDA data

Soule Medical

Primary DI
00810082224924
Brand
Soule Medical
Company
SOULE CO., THE
Model
WF1003
Catalog number
WF1003
Device description
Wilson Frame Style Positioning Kits - Frame Pad Sleeves (Set of 2) , Drape Protector, Bar Protector , Laminectomy Arm Cradles
Published
2022-09-08
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

Product Codes#

Code, Name table
CodeName
CCXSupport, Patient Position

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810082224924PackageGS16In Commercial Distribution
00810082223347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810082224924008100822249248100822249240810082224924
00810082223347008100822233478100822233470810082223347

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

Regulatory Flags#

DUNS number
032801706
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
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 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
00810082221374Soule MedicalRUSOPC01RUSOPC012023-01-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196413737MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-04-27
10080196413256MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
10080196413485MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
10080196413690MEDLINEMEDLINE INDUSTRIES, INC.CCX2026-03-30
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
07613327632859SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327632866SageSAGE PRODUCTS, LLCCCX2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
10197344149834MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-22
10197344149803MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
10197344149810MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
10197344149827MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-12
G242SB03RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB07SDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB12RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SS03DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-09
G242SB01RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SB05SDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SB10RDBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS01DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS04DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS05DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS08DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS10DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS11DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
G242SS15DBKMR9Techno-AideTechno-Aide, Inc.CCX2025-09-05
10197344161034MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-07-28
10197344158768MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-06-30
10197344100392MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-04-05
10080196413805MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-01-22