Duns Number:006309355
Device Description: Sterilization tubing with indicator
Catalog Number
-
Brand Name
Nyclave Tubing 6" X 100' with Indicator
Version/Model Number
113610
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
KCT
Product Code Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Public Device Record Key
1d17c3fb-8370-410c-bdbc-5ea0be721569
Public Version Date
October 05, 2022
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
20302731136107
Quantity per Package
36
Contains DI Package
10302731136100
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
shipping box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 138 |
2 | A medical device with a moderate to high risk that requires special controls. | 85 |