Duns Number:138041277
Device Description: Threaded IM Nail 2.1mm, 30mm, SS
Catalog Number
IMN2.1-30 S
Brand Name
SmallThreadedIMNail 2.1mm (sst)
Version/Model Number
IMN2.1-30 S
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
-
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
K211783
Product Code
HWC
Product Code Name
Screw, fixation, bone
Public Device Record Key
6078a92f-0f12-4cf5-bbea-13ae6e901d04
Public Version Date
September 28, 2021
Public Version Number
1
DI Record Publish Date
September 20, 2021
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 | 555 |
2 | A medical device with a moderate to high risk that requires special controls. | 1934 |