Duns Number:114152184
Device Description: Histofreezer Kit, U.S., 60MC2 +10
Catalog Number
-
Brand Name
Histofreezer
Version/Model Number
1001-0375
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GEH
Product Code Name
Unit, Cryosurgical, Accessories
Public Device Record Key
1b955f5d-a60b-455c-8a99-92b5ed70592d
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
September 15, 2016
Package DI Number
10608337000556
Quantity per Package
5
Contains DI Package
00608337000559
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 3 |