Duns Number:242049828
Catalog Number
412127
Brand Name
Laguna Sand SBF 230V
Version/Model Number
412127
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
-
Product Code
LGX
Product Code Name
Table, Examination, Medical, Powered
Public Device Record Key
10f648a6-48c5-402e-be9b-9e53ba824269
Public Version Date
August 14, 2018
Public Version Number
3
DI Record Publish Date
July 18, 2017
Package DI Number
00667259000597
Quantity per Package
1
Contains DI Package
00667259000184
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
skid
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 52 |
2 | A medical device with a moderate to high risk that requires special controls. | 3 |