DEVICE: N/A (00810050243216)
Device Identifier (DI) Information
N/A
9090
In Commercial Distribution
DOMICO MED-DEVICE, LLC
9090
In Commercial Distribution
DOMICO MED-DEVICE, LLC
AQUILION ONE HEAD HOLDER KIT. Includes: 9091 - HOLDER, AQUILION ONE CARBON FIBER (00810050241212), 9092 - PAD, AQUILION ONE ADULT HOLDER (00810050241380), 9093 - PAD, AQUILION ONE CHILD HOLDER (00810050241397), 9094 - PAD, AQUILION ONE PEDIATRIC HOLDER (00810050242448), 9095 - PAD, AQUILION ONE WEDGE (00810050241403), 9096 - WEDGE, TAPER, 1.5” x 3.5” x 3” (10810050243008), 9097 - STRAP, VELTEX, 2” x 22” (10810050242896)
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| Yes | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 41058 | Multifunction body cushion |
A soft pillow or pad designed to provide support and comfort to a user's body part(s) in a variety of locations and positions, or to assist the user to fulfill a functional requirement involving various body parts. The device can be designed in a number of configurations that include a combined armrest-back support device, or an adjustable device.
|
Active | false |
| 61132 | 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.
|
Active | false |
| 61131 | Radiological general body-part positioner |
A device intended to facilitate adequate positioning and immobilization of a patient’s body part during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures; it is not dedicated to a specific part of the body. The device is in the form of a frame, board, cushion, or preformed pad that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| IWY | Holder, Head, Radiographic |
| CCX | Support, Patient Position |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
70dec5d1-d5c4-4fb0-b275-8ae439166ee5
October 02, 2020
1
September 24, 2020
October 02, 2020
1
September 24, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined