Duns Number:618214410
Device Description: Double Decker Micro Sterilization Tray w/ silicone finger mats & dome lid, 6" x 10" x 2", Double Decker Micro Sterilization Tray w/ silicone finger mats & dome lid, 6" x 10" x 2", autoclavable plastic
Catalog Number
030-110D
Brand Name
Hayden Medical
Version/Model Number
030-110D
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
7163f475-dea5-4a48-9be7-e5a1a47b21f3
Public Version Date
August 01, 2022
Public Version Number
1
DI Record Publish Date
July 22, 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 |