Duns Number:122240021
Device Description: Accessory to Models 1220 ArcCHECK and 1220-MR ArcCHECK-MR.
Catalog Number
12200001Z
Brand Name
ArcCHECK Cavity Plug
Version/Model Number
12200001Z
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Conditional
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LHO
Product Code Name
Instrument, Quality-Assurance, Radiologic
Public Device Record Key
d5c5ec64-235d-4bc5-b4b5-5f3c780fe6a9
Public Version Date
April 17, 2019
Public Version Number
5
DI Record Publish Date
January 14, 2017
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 | 26 |
2 | A medical device with a moderate to high risk that requires special controls. | 112 |