Duns Number:032705659
Catalog Number
-
Brand Name
Nut and Gland
Version/Model Number
10-810-52
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
BYX
Product Code Name
Tubing, Pressure And Accessories
Public Device Record Key
7c254dc4-779e-435a-b741-2e98410df8ac
Public Version Date
August 05, 2022
Public Version Number
2
DI Record Publish Date
August 04, 2020
Package DI Number
30641043810525
Quantity per Package
50
Contains DI Package
10641043810521
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 | 120 |
2 | A medical device with a moderate to high risk that requires special controls. | 728 |