FDA.report

Soule Medical

Primary DI
00810082224955
Brand
Soule Medical
Company
SOULE CO., THE
Model
WF1008
Catalog number
WF1008
Device description
Wilson Frame Style Positioning Kits - Frame Pad Sleeves (Set of 2) , Bar Protector, 7" Comfort Foam Headrest, Laminectomy Arm Cradles
Published
2022-09-14
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
false

Related Records

Product Codes

CodeName
CCXSupport, Patient Position

Product Code Classifications

CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810082224955PackageGS16In Commercial Distribution
00810082223378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810082224955008100822249558100822249550810082224955
00810082223378008100822233788100822233780810082223378

GMDN Terms

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

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 DIBrandModelCatalogPublished
10810082225010Soule MedicalPFC100PFC1002024-04-18
10810082225027Soule MedicalTP3000NBDSTP3000NBDS2024-04-18
00810082221534Soule MedicalRUSOPSRH05RUSOPSRH052023-07-06
00810082220209Soule MedicalRG2150RG21502022-10-12
00810082220216Soule MedicalRG2150-TRG2150-T2022-10-12
00810082220278Soule MedicalRG2175RG21752022-10-12
00810082220544Soule MedicalRG2370RG23702022-10-12
00810082224566Soule MedicalSKHP1000SKHP10002022-09-23
00810082220001Soule Medical HR101HR1012022-09-14
00810082220964Soule MedicalHR101-CCHR101-CC2022-09-14
00810082220971Soule MedicalHR104-CCHR104-CC2022-09-14
00810082220988Soule MedicalLP100-CCLP100-CC2022-09-14
00810082220995Soule MedicalLP200-CCLP200-CC2022-09-14
00810082221008Soule MedicalMSP-L-CCMSP-L-CC2022-09-14
00810082221015Soule MedicalMSP-R-CCMSP-R-CC2022-09-14
00810082221350Soule MedicalWLH101-CCWLH101-CC2022-09-14
00810082221725Soule MedicalBBP3040BBP30402022-09-14
00810082221732Soule MedicalBBP3040GBBP3040G2022-09-14
00810082221749Soule MedicalBBP3076BBP30762022-09-14
00810082221756Soule MedicalBBP4036BBP40362022-09-14

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