Duns Number:307332705
Device Description: Radiation Shield with Top shield for the Intelli-C X-ray system. A lead curtain for protec Radiation Shield with Top shield for the Intelli-C X-ray system. A lead curtain for protection against stray radiation during x-ray examination. A cover above the table protects the user against stray radiation from the patient.
Catalog Number
-
Brand Name
Intelli-C Accessory
Version/Model Number
03284050
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K173631
Product Code
JAA
Product Code Name
System, X-Ray, Fluoroscopic, Image-Intensified
Public Device Record Key
58279745-9fae-45f6-8b84-7d9d2031de4b
Public Version Date
April 26, 2021
Public Version Number
1
DI Record Publish Date
April 16, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |