Duns Number:713565195
Device Description: This kit is used to install a wireless foot switch transmitter/receiver onto DR-XD 3000FX/ This kit is used to install a wireless foot switch transmitter/receiver onto DR-XD 3000FX/DR-XD 3000MX.(The wireless foot switch transmitter and receiver are included.)
Catalog Number
-
Brand Name
Wireless foot switch kit
Version/Model Number
DR-XD 3000 WIRELESS F/S E
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"
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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
-
Product Code
JAA
Product Code Name
System, X-Ray, Fluoroscopic, Image-Intensified
Public Device Record Key
b51a85a4-5dc8-44ad-8e12-5f74f16facb7
Public Version Date
January 05, 2022
Public Version Number
1
DI Record Publish Date
December 28, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 43 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 324 |
| 3 | A medical device with high risk that requires premarket approval | 1 |