Duns Number:597723837
Device Description: ITL Essentials™ Sharps Passing Tray is intended for safe transfer of sharp instruments suc ITL Essentials™ Sharps Passing Tray is intended for safe transfer of sharp instruments such as surgical scalpels and capped syringes during surgery. For single use only
Catalog Number
A500102
Brand Name
ITL Essentials™ Sharps Passing Tray, Non-sterile
Version/Model Number
A500102
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
Yes
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
FSM
Product Code Name
Tray, Surgical, Instrument
Public Device Record Key
0b7fc1e9-c43f-4200-847c-7eb05c8eecaf
Public Version Date
September 28, 2020
Public Version Number
1
DI Record Publish Date
September 20, 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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |