FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756018029
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
8753-01
Catalog number
8753-01
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
00749756018029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00749756018029007497560180297497560180290749756018029

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
00749756389181DeRoyal81-1020SU81-1020SU2026-09-21
00749756389204DeRoyal81-1020REF81-1020REF2026-09-21
00749756399258DeRoyal46-326XBNS46-326XBNS2026-09-21
00749756400442DeRoyal77-40111877-4011182026-09-21
00749756985475DeRoyalNP-790NP-7902026-09-21
00749756985963DeRoyalNP-7300-01NP-7300-012026-09-21
00749756985994DeRoyalNP-7300NP-73002026-09-21
00749756986250DeRoyalNP-7300NNP-7300N2026-09-21
00749756394666DeRoyal47-820KG47-820KG2026-09-18
00749756397193DeRoyal47-813KG-0147-813KG-012026-09-18
00749756397339DeRoyal15410002154100022026-09-18
00749756397346DeRoyal15410003154100032026-09-18
00749756400800DeRoyal32-219532-21952026-09-18
00749756401289DeRoyalNP-7000-GPSNP-7000-GPS2026-09-18
00749756401678DeRoyal13-809A-01-COSM13-809A-01-COSM2026-09-18
00749756401692DeRoyalNP-6007U-01NP-6007U-012026-09-18
00749756401708DeRoyal46-LB19546-LB1952026-09-18
00749756401715DeRoyal46-LB38546-LB3852026-09-18
00749756401739DeRoyalM60-SF510TM60-SF510T2026-09-18
00749756401746DeRoyalNP-120UNP-120U2026-09-18

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
00749756018036DeRoyalDEROYAL 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