Duns Number:791619393
Device Description: ATP Screw, 240 MM, Sterile, 5/Box
Catalog Number
UL-0378S-05
Brand Name
TSI
Version/Model Number
UL-0378S
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MDM
Product Code Name
Instrument, Manual, Surgical, General Use
Public Device Record Key
784cbd8b-2a9a-4aea-9e50-4d77760882c3
Public Version Date
July 25, 2022
Public Version Number
1
DI Record Publish Date
July 15, 2022
Package DI Number
10843059126065
Quantity per Package
5
Contains DI Package
00843059126068
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 | 2398 |
2 | A medical device with a moderate to high risk that requires special controls. | 51 |