Duns Number:089645059
Device Description: Reduction Forceps Narrow
Catalog Number
110630
Brand Name
Reduction Forceps Narrow
Version/Model Number
110630
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
K152000
Product Code
HRS
Product Code Name
Plate, Fixation, Bone
Public Device Record Key
46d388df-0950-4c8a-aea3-af9a340a4594
Public Version Date
September 28, 2022
Public Version Number
1
DI Record Publish Date
September 20, 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 | 60 |
2 | A medical device with a moderate to high risk that requires special controls. | 846 |