Duns Number:051420107
Device Description: MB CryoTher Kit 162ml ORM
Catalog Number
-
Brand Name
Moore Medical
Version/Model Number
23499
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
a493fb71-7a89-4c2d-9e4b-fff0801894a7
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
December 09, 2016
Package DI Number
40607415001745
Quantity per Package
1
Contains DI Package
10607415001737
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 4 |