AccessGUDID - DEVICE: NA (00810050245357)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 7
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: DOMICO MED-DEVICE, LLC

Primary DI Number: 00810050245357
Issuing Agency: GS1
Commercial Distribution End Date: February 17, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 081253414 *Terms of Use

Device Description: KIT, SMALL. Includes: 128 – WEDGE, 3” x 10” x 10” (00810050240819), 129 – WEDGE, 4.63" x 10" x 10" (00810050240314), 130 – WEDGE, 10" x 10" x 10" (00810050240826), 140 – WEDGE, 6" x 10" x 10" (00810050240369)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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
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
KXJ	Table, Radiologic
CCX	Support, Patient Position

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ade147c9-f34d-44f6-8686-f9b317ba6b96
Public Version Date: February 22, 2023
Public Version Number: 2
DI Record Publish Date: June 22, 2022