Home GUDID 00840216112285 PERFORMANCE HEALTH
Primary DI 00840216112285
Brand PERFORMANCE HEALTH
Company Asp Global, LLC
Model A545803
Device description Rolyan Shoulder Immobilizer, Large
Published 2022-05-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name NOD Board, Arm (With Cover), Non-Sterile
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NOD Board, Arm (With Cover), Non-Sterile General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840216112285 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 00840216112285 00840216112285 840216112285 0840216112285
GMDN Terms# Term, Definition table Term Definition Shoulder immobilizer, reusable A non-rigid device used to temporarily immobilize or limit abduction of the shoulder joint to support healing of an injury or a surgical wound. It is typically used postoperatively and for post traumatic treatment of injuries in the shoulder and upper arm areas (e.g., distortion/contusion, dislocation/luxation, and postoperative support). It will typically consist of layered fabric, straps, buckles, fasteners and will eliminate most of the work involved with bandaging. This is a reusable device.
Regulatory Flags# DUNS number 080361159 Device count 1 Premarket exempt true Contains natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10840118400593 MTI Medical Technology Industries, Inc. NOD 2022-12-30 10840118400609 MTI Medical Technology Industries, Inc. NOD 2022-12-30 10840118400616 MTI Medical Technology Industries, Inc. NOD 2022-12-30 10840118400623 MTI Medical Technology Industries, Inc. NOD 2022-12-30 10840118400630 MTI Medical Technology Industries, Inc. NOD 2022-12-30 10840118400647 MTI Medical Technology Industries, Inc. NOD 2022-12-30 10840118400654 MTI Medical Technology Industries, Inc. NOD 2022-12-30 10840118400661 MTI Medical Technology Industries, Inc. NOD 2022-12-30 10840118400678 MTI Medical Technology Industries, Inc. NOD 2022-12-30 10840118400685 MTI Medical Technology Industries, Inc. NOD 2022-12-30 10840118400692 MTI Medical Technology Industries, Inc. NOD 2022-12-30 10840118400708 MTI Medical Technology Industries, Inc. NOD 2022-12-30 10840118400715 MTI Medical Technology Industries, Inc. NOD 2022-12-30 10840118400722 MTI Medical Technology Industries, Inc. NOD 2022-12-30 10840118400739 MTI Medical Technology Industries, Inc. NOD 2022-12-30 10840118400746 MTI Medical Technology Industries, Inc. NOD 2022-12-30 10840118400753 MTI Medical Technology Industries, Inc. NOD 2022-12-30 10840118400760 MTI Medical Technology Industries, Inc. NOD 2022-12-30 10840118400777 MTI Medical Technology Industries, Inc. NOD 2022-12-30 10840118400784 MTI Medical Technology Industries, Inc. NOD 2022-12-30 10840118400791 MTI Medical Technology Industries, Inc. NOD 2022-12-30 10840118400807 MTI Medical Technology Industries, Inc. NOD 2022-12-30 10840118400814 MTI Medical Technology Industries, Inc. NOD 2022-12-30 10840118400821 MTI Medical Technology Industries, Inc. NOD 2022-12-30 10840118400838 MTI Medical Technology Industries, Inc. NOD 2022-12-30 10840118400845 MTI Medical Technology Industries, Inc. NOD 2022-12-30 10840118400852 MTI Medical Technology Industries, Inc. NOD 2022-12-30 10840118400869 MTI Medical Technology Industries, Inc. NOD 2022-12-30 10840118400876 MTI Medical Technology Industries, Inc. NOD 2022-12-30 10840118400883 MTI Medical Technology Industries, Inc. NOD 2022-12-30