AccessGUDID - DEVICE: Codonics DirectVista Thermal Film, 1114-DVB5 (00814905020892)

GUDID

Device Identifier (DI) Information

Brand Name: Codonics DirectVista Thermal Film, 1114-DVB5
Version or Model: 1114-DVB5
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CODONICS INC.

Primary DI Number: 00814905020892
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 101533727 *Terms of Use

Device Description: 1114-DVB5 Blue Base Film (100 sheet box)

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:	Yes
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?
63183	Medical printer film	A thin transparent film intended to be used with an appropriate printer to produce a hard copy of a medical image generated by a digital diagnostic radiological system [during, e.g., angiography, magnetic resonance imaging (MRI), nuclear medicine, ultrasound (US), computed tomography (CT)]; it is not photographically light sensitive. It is intended to assist high-quality diagnostic evaluation and is used as a hard-copy alternative to, e.g., medical printer paper or photographically sensitive x-ray film. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IWZ	Film, Radiographic

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
Handling Environment Humidity: between 10 and 70 Percent (%) Relative Humidity
Handling Environment Temperature: between 32 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d7700994-2a00-43a7-8c38-c6116257fa14
Public Version Date: February 13, 2020
Public Version Number: 1
DI Record Publish Date: February 05, 2020