Duns Number:618214410
Device Description: Micro Sterilization Tray w/ silicone finger mat, 4" x 7-1/2" x 1-1/2", autoclavable plasti Micro Sterilization Tray w/ silicone finger mat, 4" x 7-1/2" x 1-1/2", autoclavable plastic
Catalog Number
030-105.5
Brand Name
Hayden Medical
Version/Model Number
030-105.5
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
-
Product Code
LRP
Product Code Name
TRAY, SURGICAL
Public Device Record Key
84eef520-8d6c-47d3-800e-4b4be2b7f6d8
Public Version Date
July 27, 2022
Public Version Number
1
DI Record Publish Date
July 19, 2022
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 | 2893 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 195 |