AccessGUDID - DEVICE: Under the Table Cassette Holder, Siemens Compatible (B365529500)

GUDID

Device Identifier (DI) Information

Brand Name: Under the Table Cassette Holder, Siemens Compatible
Version or Model: 52-950
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Aktina Corp.

Primary DI Number: B365529500
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 787178920 *Terms of Use

Device Description: No description.

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?
36914	Radiation therapy port film device	A motorized cassette holder that is either mounted on the gantry of, e.g., a linear accelerator system or other radiation therapy system, or is designed as an independent mobile stand, and is used to position and support a film cassette. The x-ray or radiographic film in the cassette is exposed in order to allow the operators to monitor and adjust the conformity between the planned radiation treatment and the treatment delivered to the patient.	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: ff9d7ea8-896b-41d8-af5a-b235755c2f56
Public Version Date: May 31, 2021
Public Version Number: 1
DI Record Publish Date: May 21, 2021