Duns Number:179135769
Device Description: Biopsy, Blue
Catalog Number
4087
Brand Name
Tissue-Tek® Uni-Cassette®
Version/Model Number
4087
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
Yes
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
IDZ
Product Code Name
CASSETTES, TISSUE
Public Device Record Key
2451f18e-8195-4fbf-a117-fee5afd61ab5
Public Version Date
August 30, 2022
Public Version Number
4
DI Record Publish Date
December 18, 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 | 733 |