Duns Number:315539452
Device Description: Leica Biosystems Accessory
Catalog Number
14046437058
Brand Name
Adapter for DRS601/Varistain XY
Version/Model Number
000000014046437058
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KIM
Product Code Name
DEVICE FOR SEALING MICROSECTIONS
Public Device Record Key
40b4b46e-e67f-4f8a-aaba-f4c223a1b7a2
Public Version Date
August 20, 2020
Public Version Number
2
DI Record Publish Date
December 04, 2018
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 | 97 |