Duns Number:597723837
Device Description: ITL Essentials™ Needle Mat is a plastic lidded tray for collecting, counting and temporari ITL Essentials™ Needle Mat is a plastic lidded tray for collecting, counting and temporarily storing used sharps (suture needles and blades) in the surgical suite.
Catalog Number
A500101
Brand Name
ITL Essentials™ Needle Mat (Sterile)
Version/Model Number
A500101
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
a9f51e82-7132-48ef-83ad-fac2cd717e8e
Public Version Date
October 21, 2020
Public Version Number
2
DI Record Publish Date
September 20, 2020
Package DI Number
19555240401370
Quantity per Package
16
Contains DI Package
19555240401080
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Box
| 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 |