Duns Number:751993028
Catalog Number
-
Brand Name
ALIF Trial Caddy
Version/Model Number
W32-04-0300
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
K172019
Product Code
KCT
Product Code Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Public Device Record Key
5e3b484a-48ae-443e-afad-81736d2217d8
Public Version Date
September 16, 2022
Public Version Number
7
DI Record Publish Date
May 27, 2019
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 | 1701 |
2 | A medical device with a moderate to high risk that requires special controls. | 3746 |