FDA.reportPublic FDA data

Primspine

Primary DI
08434048352784
Brand
Primspine
Company
PRIM S.A.
Model
PRS615G OS
Catalog number
824726
Device description
PRIMSPINE MAMMY Pregnancy Girdle, gray
Published
2024-03-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
QSBOrthosis, Truncal, Pregnancy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QSBOrthosis, Truncal, PregnancyPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08434048352784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08434048352784084340483527848434048352784

GMDN Terms#

Term, Definition table
TermDefinition
Multiple spinal region orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass two or more regions of the spine (e.g., sacroiliac, lumbosacral, thoracolumbosacral) to support or immobilize deformities, fractures, sprains, or strains of the spine, and may additionally provide support for the abdomen. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
462011560
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08431082070186ComforsilCC209S2024-03-08
08431082070193ComforsilCC209M2024-03-08
08431082070209ComforsilCC209L2024-03-08
08431082070216ComforsilCC209XL2024-03-08
08431082070391ComforsilCC218M2024-03-08
08431082070773ComforsilCC2452024-03-08
08431082070810ComforsilCC206S2024-03-08
08431082070827ComforsilCC206M2024-03-08
08431082070834ComforsilCC206L2024-03-08
08431082070841ComforsilCC218S8003982024-03-08
08431082070858ComforsilCC218L8003962024-03-08
08431082070896ComforsilCC2492024-03-08
08431082070902ComforsilCC2508004232024-03-08
08434048106349ComforgelCG04017364482024-03-08
08434048106554ComforgelCG05017364692024-03-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04823097717707"TM ""Rehabilitimed"" GL-1 S Comfort"REABILITIMED TOVQSB2025-05-05
04823097717714"TM ""Rehabilitimed"" GL-1 M Comfort"REABILITIMED TOVQSB2025-05-05
04823097717721"TM ""Rehabilitimed"" GL-1 XXXL Comfort"REABILITIMED TOVQSB2025-05-05
04823097717738"TM ""Rehabilitimed"" GL-1 XXL Comfort"REABILITIMED TOVQSB2025-05-05
04823097717745"TM ""Rehabilitimed"" GL-1 XL Comfort"REABILITIMED TOVQSB2025-05-05
04823097717752"TM ""Rehabilitimed"" GL-1 L Comfort"REABILITIMED TOVQSB2025-05-05
04823097718933"TM ""Rehabilitimed"" GL-1 XXXL Comfort"REABILITIMED TOVQSB2025-05-05
04823097718940"TM ""Rehabilitimed"" GL-1 XXL Comfort"REABILITIMED TOVQSB2025-05-05
04823097718957"TM ""Rehabilitimed"" GL-1 XL Comfort"REABILITIMED TOVQSB2025-05-05
04823097718964"TM ""Rehabilitimed"" GL-1 M Comfort"REABILITIMED TOVQSB2025-05-05
04823097718971"TM ""Rehabilitimed"" GL-1 S Comfort"REABILITIMED TOVQSB2025-05-05
04823097718988"TM ""Rehabilitimed"" GL-1 L Comfort"REABILITIMED TOVQSB2025-05-05