AccessGUDID - DEVICE: Couchtop Panel (00841439104491)

GUDID

Device Identifier (DI) Information

Brand Name: Couchtop Panel
Version or Model: MTIL300512
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MTIL300512
Company Name: MEDTEC, INC.

Primary DI Number: 00841439104491
Issuing Agency: GS1
Commercial Distribution End Date: February 16, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 103977526 *Terms of Use

Device Description: Reusable non-sterile solid couchtop panel for use with Siemens ZXT system

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):	Yes
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?
40897	Indexed-immobilization patient positioning system	A assembly of devices used primarily in radiation therapy applications, and consisting of an indexed treatment or imaging table (couch) that contains locking interfaces used to attach various positioning and immobilization devices to numbered or lettered (indexing) points on the table. It is used to ensure both adequate positioning and immobilization of a patient and to help ensure reproducible alignment between a target portion of the patient's anatomy and the radiation beams or fields used in radiation therapy treatments, diagnostic imaging studies. It may accommodate a variety of anatomically targeted patient positioning and immobilization attachments.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IXQ	Table, radiographic, stationary top

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K973842	000

Device Exempt from Premarket Submission: No 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
Special Storage Condition, Specify: Keep away from sunlight
Storage Environment Temperature: between 52 and 85 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Width: 53 Inch
Length: 80 Centimeter

Device Record Status

Public Device Record Key: 8255af92-e990-4801-ac2b-fd594e3c35e4
Public Version Date: February 17, 2020
Public Version Number: 6
DI Record Publish Date: August 02, 2017