AccessGUDID - DEVICE: Del Medical/Universal (00858340006349)

GUDID

Device Identifier (DI) Information

Brand Name: Del Medical/Universal
Version or Model: VS300
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Del Medical, Inc.

Primary DI Number: 00858340006349
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078671236 *Terms of Use

Device Description: The VS300 is a wall-mounted radiographic cassette holder. A wall-mounted radiographic cassette holder is a device that is a support intended to hold and position radiographic cassettes for a radiographic exposure for medical use.

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?
14473	X-ray film cassette holder	A device designed to position and hold the cassettes containing x-ray film during medical or dental imaging or radiation therapy procedures. It is used in conjunction with multiformat cameras and diagnostic imaging and radiation therapy modalities, e.g., nuclear medicine systems, ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IXY	Holder, Radiographic Cassette, Wall-Mounted

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: fac2d31b-5489-49fd-b228-84df83c04e54
Public Version Date: April 25, 2022
Public Version Number: 1
DI Record Publish Date: April 15, 2022