Duns Number:604056226
Device Description: Plastic Sterilization Tray w/Slotted Base & Silicone Mat; 6.5" x 4.0" x 0.75" (165 x 102 x Plastic Sterilization Tray w/Slotted Base & Silicone Mat; 6.5" x 4.0" x 0.75" (165 x 102 x 19mm)
Catalog Number
-
Brand Name
Key Surgical Plastic Sterilization Trays
Version/Model Number
PST-2100SB
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)
-
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
e508b223-54da-4576-ad33-6317dadc5c03
Public Version Date
September 16, 2022
Public Version Number
5
DI Record Publish Date
December 11, 2020
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 | 326 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 219 |