Duns Number:179135769
Device Description: White, LWS, with one storage cabinet
Catalog Number
4171-02
Brand Name
Tissue-Tek® Uni-Cassette®
Version/Model Number
4171-02
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
KDT
Product Code Name
CONTAINER, SPECIMEN MAILER AND STORAGE, STERILE
Public Device Record Key
e693bf1b-c6d3-4e46-8b7f-e2571dee1062
Public Version Date
August 30, 2022
Public Version Number
4
DI Record Publish Date
January 22, 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 | 733 |