Home GUDID 00645517327983 Trulife
Primary DI 00645517327983
Brand Trulife
Company TRULIFE LIMITED
Model 015COH1
Device description PED HIP ABDUCT ORTHOSIS SM
Published 2022-12-31
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true
Single use true Product Codes# Code, Name table Code Name IOZ SPLINT, ABDUCTION, CONGENITAL HIP DISLOCATION
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class IOZ Splint, Abduction, Congenital Hip Dislocation Physical Medicine 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00645517327983 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00645517327983 00645517327983 645517327983 0645517327983
GMDN Terms# Term, Definition table Term Definition Infant hip harness A prefabricated (non-customized) soft orthopaedic orthosis intended to be worn by an infant to help keep the hips and knees bent and the thighs spread apart, typically to treat developmental dysplasia of the hip (DDH). Also referred to as a Pavlik harness, it is in the form of a vest-like harness with adjustable padded straps whereby the infant’s legs are suspended from the shoulders and chest. This is a reusable device.
Regulatory Flags# DUNS number 289728891 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published H93350840100 Span-America SPAN-AMERICA MEDICAL SYSTEMS, INC. IOZ 2023-06-08 H93350840110 Span-America SPAN-AMERICA MEDICAL SYSTEMS, INC. IOZ 2023-06-08 H93350840120 Span-America SPAN-AMERICA MEDICAL SYSTEMS, INC. IOZ 2023-06-08 H93350840210 Span-America SPAN-AMERICA MEDICAL SYSTEMS, INC. IOZ 2023-06-08 H93350840245 Span-America SPAN-AMERICA MEDICAL SYSTEMS, INC. IOZ 2023-06-08 H93350840250 Span-America SPAN-AMERICA MEDICAL SYSTEMS, INC. IOZ 2023-06-08 H93300267100100 Span-America SPAN-AMERICA MEDICAL SYSTEMS, INC. IOZ 2023-06-07 H93300267100200 Span-America SPAN-AMERICA MEDICAL SYSTEMS, INC. IOZ 2023-06-07 H93300267100300 Span-America SPAN-AMERICA MEDICAL SYSTEMS, INC. IOZ 2023-06-07 H93300267500000 Span-America SPAN-AMERICA MEDICAL SYSTEMS, INC. IOZ 2023-06-07 00645517327990 Trulife TRULIFE LIMITED IOZ 2022-12-31 00645517328003 Trulife TRULIFE LIMITED IOZ 2022-12-31 G088DSHKOR0 Panacea Blake Manufacturing, Inc. IOZ 2022-09-06 G088DSHKOS0 Panacea Blake Manufacturing, Inc. IOZ 2022-09-06 G088HKOR0 BMI Blake Manufacturing, Inc. IOZ 2022-08-15 G088HKOS0 BMI Blake Manufacturing, Inc. IOZ 2022-08-15 00749756018029 DeRoyal DEROYAL INDUSTRIES, INC. IOZ 2021-07-29 00749756018036 DeRoyal DEROYAL INDUSTRIES, INC. IOZ 2021-07-29 00749756018043 DeRoyal DEROYAL INDUSTRIES, INC. IOZ 2021-07-29 00889024369207 N/A ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. IOZ 2020-12-15 00889024369214 N/A ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. IOZ 2020-12-15 00889024369221 N/A ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. IOZ 2020-12-15 00889024369283 N/A ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. IOZ 2020-12-15 00696588003580 Slimline™ Abduction Pillow Innovative Medical Products, Inc IOZ 2020-06-02 00696588003597 Slimline™ Abduction Pillow Innovative Medical Products, Inc IOZ 2020-06-02 00696588003795 Pediatric Abduction Pillow Innovative Medical Products, Inc IOZ 2020-06-02 00696588003818 Universal Abduction Pillow Innovative Medical Products, Inc IOZ 2020-06-02 00696588005447 Slimline™ Abduction Pillow Innovative Medical Products, Inc IOZ 2020-06-02 00696588005485 Pediatric Abduction Pillow Innovative Medical Products, Inc IOZ 2020-06-02 00696588006116 Universal Abduction Pillow Innovative Medical Products, Inc IOZ 2020-06-02