FDA.report

Rigid head rest

Primary DI
04046768028906
Brand
Rigid head rest
Company
MAQUET GmbH
Model
100282A0
Published
2022-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IWYHolder, head, radiographic

Product Code Classifications

CodeDeviceSpecialtyClass
IWYHolder, Head, RadiographicRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046768028906PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046768028906040467680289064046768028906

GMDN Terms

TermDefinition
Radiological headrestA 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
315435859
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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04046768151468Connection Bracket100405A02025-11-30
04046768151475Connection Bracket100405F02025-11-30
04046768151567Traction bar with ball for 1160 and 7700100740B02025-11-30
04046768151574Traction bar for 1160 and 7700100741B02025-11-30
04046768112704Disposable cover100729A02025-06-17
04046768146037Carbon Fiber Table Top116016A02025-01-27
04046768146044Carbon Fiber Table Top116016A12025-01-27
04046768146051Carbon Fiber Table Top116016A22025-01-27
04046768146853Joystick116094A02025-01-27
04046768001954Femur counter traction post table top100485B02022-12-08
04046768148321Retrofit kit head fixation I116036A02024-11-21
04046768148338Extension plate116033DC2024-11-21
04046768148345Extension plate116033BC2024-11-21
04046768148352Extension plate116033GC2024-11-21
04046768150973Extension plate116033FC2024-11-21
04046768151208Retrofit kit head fixation II116036B02024-11-21
04046768145993Universal Remote Control100925B02024-09-18
04046768148475Table width extension, long100175F02024-06-03
04046768148499Bariatric OR Table Set100174F02024-06-03

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