Duns Number:119193803
Device Description: Instrument tray for dental tools
Catalog Number
7141914 BLU
Brand Name
Cool Cassette 2 Size 7 Instrument Tray True Blue
Version/Model Number
7141914 BLU
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"
Yes
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
FSM
Product Code Name
Tray, Surgical, Instrument
Public Device Record Key
ac811f61-7ea4-4110-b36d-d0760a63a45d
Public Version Date
September 16, 2022
Public Version Number
5
DI Record Publish Date
December 04, 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 | 93 |
2 | A medical device with a moderate to high risk that requires special controls. | 2 |