DEVICE: NA (00810050242165)
Device Identifier (DI) Information
NA
15
Not in Commercial Distribution
DOMICO MED-DEVICE, LLC
15
Not in Commercial Distribution
DOMICO MED-DEVICE, LLC
KIT, SMALL, "I". Includes: 127 - HOLDER, CHILD AP-PA HEAD (00810050240307), 132 – SUPPORT, HEAD/NECK, 6.5” x 10” x 12” (00810050240208), 133 – REST, CERVICAL HEAD (00810050240055), 136 – WEDGE, 2.25” x 8” x 10” (00810050240338), 138 – WEDGE, 3.75” x 8” x 10” (00810050240161), 139 – WEDGE, 7” x 7” x 10” (00810050240345), 169 – RECTANGLE, 3” x 7.5” x 10” (00810050240413)
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? |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| KXJ | Table, Radiologic |
| 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
ff02482b-730a-4cb9-af2c-f624db0d7ec2
February 22, 2023
2
September 24, 2020
February 22, 2023
2
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