Duns Number:481999654
Device Description: Cannulated Screw
Catalog Number
611270S
Brand Name
ASNIS
Version/Model Number
611270S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
HTN
Product Code Name
WASHER, BOLT NUT
Public Device Record Key
16b74759-fcb7-4dc7-9722-4ab25fb25eed
Public Version Date
May 03, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2015
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 | 2606 |
2 | A medical device with a moderate to high risk that requires special controls. | 9953 |
3 | A medical device with high risk that requires premarket approval | 186 |