Duns Number:688298116
Catalog Number
-
Brand Name
LG
Version/Model Number
21HK512D
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K191864
Product Code
PGY
Product Code Name
Display, Diagnostic Radiology
Public Device Record Key
f9a56e36-d96f-4058-b49c-a33802ca4ef5
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
December 10, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 14 |
2 | A medical device with a moderate to high risk that requires special controls. | 18 |