Home GUDID 50749756377138 DeRoyal
Primary DI 50749756377138
Brand DeRoyal
Company DEROYAL INDUSTRIES, INC.
Model M2028-P
Catalog number M2028-P
Device description Limb Holder Wrist/Ankle
Published 2023-02-06
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name FMQ Restraint, protective
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FMQ Restraint, Protective General Hospital 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 50749756377138 Package GS1 36 In Commercial Distribution 00749756377133 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 50749756377138 50749756377138 00749756377133 00749756377133 749756377133 0749756377133
GMDN Terms# Term, Definition table Term Definition Limb/torso/head restraint, single-use A non-rigid device, typically a strap(s), band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a single-use device.
Regulatory Flags# DUNS number 096372255 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10080196310128 MEDLINE MEDLINE INDUSTRIES, INC. FMQ 2025-06-03 10748426141125 Medline-Microtek Microtek Medical LLC FMQ 2025-04-08 09010279001708 iFIX iSYS Medizintechnik GmbH FMQ 2024-07-30 09010279001715 iFIX iSYS Medizintechnik GmbH FMQ 2024-07-30 10080196281374 Medline MEDLINE INDUSTRIES, INC. FMQ 2024-05-01 M1435040070 Protective Vest No Sleeve Kenad SG Medical, Inc. FMQ 2023-09-17 10810087352766 Coulmed Coulmed Products Group LLC FMQ 2023-01-06 10810087353022 Coulmed Coulmed Products Group LLC FMQ 2023-01-06 10810087353039 Coulmed Coulmed Products Group LLC FMQ 2023-01-06 10810087353046 Coulmed Coulmed Products Group LLC FMQ 2023-01-06 10810087353053 Coulmed Coulmed Products Group LLC FMQ 2023-01-06 10190676003232 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-06 10190676003348 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-06 10190676003355 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-06 10190676005441 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-06 10190676005458 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-06 10190676005465 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-06 10190676001016 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676001085 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676001108 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002518 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002525 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002532 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002549 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002556 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002563 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002570 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002594 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002600 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002617 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05