Duns Number:793384496
Device Description: Wrist Spanning Plate
Catalog Number
131849181
Brand Name
DVR® Crosslock
Version/Model Number
131849181
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
K220244
Product Code
HRS
Product Code Name
Plate, fixation, bone
Public Device Record Key
80af6a67-ed93-4dd0-a3fe-8a1ec74c7774
Public Version Date
May 12, 2022
Public Version Number
1
DI Record Publish Date
May 04, 2022
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 | 3116 |
2 | A medical device with a moderate to high risk that requires special controls. | 5221 |