Duns Number:785335381
Device Description: Dry bath incubator, Digital, One 12-place 15ml heat block and One 4-place 50ml heat block
Catalog Number
DBL-16PL-11DP
Brand Name
LW Scientific, Inc
Version/Model Number
DBL-16PL-11DP
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
JTQ
Product Code Name
Bath, Incubators/Water, All
Public Device Record Key
13398536-6115-4792-ba17-76d27b035f71
Public Version Date
August 30, 2022
Public Version Number
3
DI Record Publish Date
May 31, 2020
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 | 94 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 28 |