Duns Number:013369913
Device Description: Thermo Clone VPS Heavy Body 2x50 ml Refill Kit
Catalog Number
4059-
Brand Name
Thermo Clone VPS
Version/Model Number
4059-
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
K082560
Product Code
ELW
Product Code Name
MATERIAL, IMPRESSION
Public Device Record Key
56cbefbe-1169-4a0e-b2eb-ddbb5e7dbd41
Public Version Date
November 11, 2019
Public Version Number
4
DI Record Publish Date
November 04, 2016
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 | 450 |
2 | A medical device with a moderate to high risk that requires special controls. | 631 |
U | Unclassified | 18 |