Duns Number:691176883
Device Description: Cryotec (10 pieces) (White)
Catalog Number
TEC010W
Brand Name
Cryotec
Version/Model Number
TEC010W
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
K162051,K162051
Product Code
MQK
Product Code Name
Labware, Assisted Reproduction
Public Device Record Key
1d2e3978-98a0-463a-94b6-30c85652ccb7
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 31, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-