FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756018036
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
8753-02
Catalog number
8753-02
Device description
Pavlik Harness
Published
2021-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IOZSPLINT, ABDUCTION, CONGENITAL HIP DISLOCATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IOZSplint, Abduction, Congenital Hip DislocationPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00749756018036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00749756018036007497560180367497560180360749756018036

GMDN Terms#

Term, Definition table
TermDefinition
Hip orthosisAn externally applied orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or improve function of the hip; it is not dedicated to infants. It is typically adjustable and comprised of components that include a hip/pelvic girdle, thigh cuff, and articulated hip portion. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00749756402699DeRoyal25-1104EU25-1104EU2026-07-22
00749756402705DeRoyal25-1104EUN25-1104EUN2026-07-22
00749756402750DeRoyal25-1401YEU25-1401YEU2026-07-22
00749756402767DeRoyal25-1403EU25-1403EU2026-07-22
00749756402781DeRoyal25-1702EU25-1702EU2026-07-22
00749756402798DeRoyal25-1702EUN25-1702EUN2026-07-22
00749756402910DeRoyal25-0403EUN25-0403EUN2026-07-22
00749756402545DeRoyal25-0103EU25-0103EU2026-07-08
00749756402552DeRoyal25-0103EUN25-0103EUN2026-07-08
00749756402569DeRoyal25-0104EU25-0104EU2026-07-08
00749756402576DeRoyal25-0104EUN25-0104EUN2026-07-08
00749756402583DeRoyal25-0105EU25-0105EU2026-07-08
00749756402590DeRoyal25-0108EU25-0108EU2026-07-08
00749756402606DeRoyal25-0201EU25-0201EU2026-07-08
00749756402613DeRoyal25-0401EU25-0401EU2026-07-08
00749756402620DeRoyal25-0401EUN25-0401EUN2026-07-08
00749756402637DeRoyal25-0402EU25-0402EU2026-07-08
00749756402644DeRoyal25-0402EUN25-0402EUN2026-07-08
00749756402651DeRoyal25-0403EU25-0403EU2026-07-08
00749756402675DeRoyal25-0801EU25-0801EU2026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
H93350840100Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-08
H93350840110Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-08
H93350840120Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-08
H93350840210Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-08
H93350840245Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-08
H93350840250Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-08
H93300267100100Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-07
H93300267100200Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-07
H93300267100300Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-07
H93300267500000Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IOZ2023-06-07
00645517327983TrulifeTRULIFE LIMITEDIOZ2022-12-31
00645517327990TrulifeTRULIFE LIMITEDIOZ2022-12-31
00645517328003TrulifeTRULIFE LIMITEDIOZ2022-12-31
G088DSHKOR0PanaceaBlake Manufacturing, Inc.IOZ2022-09-06
G088DSHKOS0PanaceaBlake Manufacturing, Inc.IOZ2022-09-06
G088HKOR0BMIBlake Manufacturing, Inc.IOZ2022-08-15
G088HKOS0BMIBlake Manufacturing, Inc.IOZ2022-08-15
00749756018029DeRoyalDEROYAL INDUSTRIES, INC.IOZ2021-07-29
00749756018043DeRoyalDEROYAL INDUSTRIES, INC.IOZ2021-07-29
00889024369207N/AZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.IOZ2020-12-15
00889024369214N/AZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.IOZ2020-12-15
00889024369221N/AZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.IOZ2020-12-15
00889024369283N/AZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.IOZ2020-12-15
00696588003580Slimline™ Abduction Pillow Innovative Medical Products, IncIOZ2020-06-02
00696588003597Slimline™ Abduction Pillow Innovative Medical Products, IncIOZ2020-06-02
00696588003795Pediatric Abduction PillowInnovative Medical Products, IncIOZ2020-06-02
00696588003818Universal Abduction PillowInnovative Medical Products, IncIOZ2020-06-02
00696588005447Slimline™ Abduction Pillow Innovative Medical Products, IncIOZ2020-06-02
00696588005485Pediatric Abduction PillowInnovative Medical Products, IncIOZ2020-06-02
00696588006116Universal Abduction PillowInnovative Medical Products, IncIOZ2020-06-02