AccessGUDID - DEVICE: Radlink Cassette (00866389000181)

GUDID

Device Identifier (DI) Information

Brand Name: Radlink Cassette
Version or Model: CAS1012
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: RADLINK, INC.

Primary DI Number: 00866389000181
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 069190036 *Terms of Use

Device Description: The Radlink Cassette is a digital imaging cassette that holds a flat panel detector during x-ray exposure and has a grid to absorb scattered radiation.This model is designed for 10"x12" plates.

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?
44823	Digital imaging cassette	A device intended to be used in diagnostic x-ray imaging to hold and shield a phosphor plate (not included) from exposure to room light during transport and insertion into a computed radiography (CR) scanner to produce a digital image of a patient radiation pattern. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K052938	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bc0dbf40-6e71-4fcb-affd-120ecf321cfa
Public Version Date: June 19, 2024
Public Version Number: 4
DI Record Publish Date: September 21, 2016