Duns Number:307332705
Device Description: Shoulder support for the Intelli-C X-ray system. The Shoulder support guides the positioni Shoulder support for the Intelli-C X-ray system. The Shoulder support guides the positioning/support of the patient during angulation towards the Trendelenburg position.
Catalog Number
-
Brand Name
Intelli-C Accessory
Version/Model Number
03283000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 11, 2022
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
30cdc566-27f5-4179-b906-47a4aa107627
Public Version Date
April 12, 2022
Public Version Number
2
DI Record Publish Date
February 19, 2019
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 |