AccessGUDID - DEVICE: Del Medical/Universal (00858340006288)

GUDID

Device Identifier (DI) Information

Brand Name: Del Medical/Universal
Version or Model: OTC18M
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Del Medical, Inc.

Primary DI Number: 00858340006288
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078671236 *Terms of Use

Device Description: An x-ray system component intended to be mounted to the ceiling, to support and facilitate position of the x-ray tube. The OTC18M does not allow for synchronized tracking or stitching.

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":	No
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?
40946	X-ray system tube support, ceiling mounted	A component of an x-ray system (diagnostic, therapeutic, radiation therapy simulator) intended to be mounted on the ceiling to mount, support and facilitate positioning of the x-ray tube assembly (not included). It typically consists of a rack with controls. The x-ray tube assembly is attached to the rack and can be moved along the rack and/or tilted. Some designs also support the movement and positioning of an image receptor assembly (e.g., C-arm assembly).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYB	Tube Mount, X-Ray, Diagnostic

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: adb580f8-40e7-4694-83b1-07ba9b0cc9ad
Public Version Date: April 25, 2022
Public Version Number: 1
DI Record Publish Date: April 15, 2022