Home GUDID 00810050243223 N/A
Primary DI 00810050243223
Brand N/A
Company DOMICO MED-DEVICE, LLC
Model 9403
Device description Infinix Forehead Pad & Strap. Includes: 21577 - PAD, FOREHEAD, .50 X 2.00 X 6.00 (00810050242585), 21578 - STRAP, FOREHEAD, 2.00 X 60.00 (00810050242592)
Published 2020-09-24
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name FMQ Restraint, Protective IWY Holder, Head, Radiographic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FMQ Restraint, Protective General Hospital 1 IWY Holder, Head, Radiographic Radiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810050243223 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 00810050243223 00810050243223 810050243223 0810050243223
GMDN Terms# Term, Definition table Term Definition Radiological headrest A non-sterile device intended to facilitate adequate positioning and immobilization of the patient's head and neck for reproducible positioning during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. The device is in the form of a frame, cushion, or preformed pad that is intended to directly contact the head, and which may be customizable for single-patient use. This is a reusable device.
Regulatory Flags# DUNS number 081253414 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true No 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 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 G242RHIAB9 Techno-Aide Techno-Aide, Inc. IWY 2023-02-13 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 10190676002624 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002631 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002693 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05 10190676002709 POSEY POSEY PRODUCTS, LLC FMQ 2022-10-05