Duns Number:486741981
Device Description: Offset cup impactors are to be used to position and seat acetabular cups into the reamed a Offset cup impactors are to be used to position and seat acetabular cups into the reamed acetabulum during hip joint replacement surgery. The cup impactor is equipped with a suitable connection system to the acetabular cup (e.g. a thread). A hammer is used to deliver the necessary impact to an anvil (or impactor disc) at the rear end of the instrument. This is an reusable device.
Catalog Number
T18303
Brand Name
Offset Cup Impactor 7/16-20 UNF Long = 3mm
Version/Model Number
T18303
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
-
Product Code
HWA
Product Code Name
Impactor
Public Device Record Key
a5b782d8-9baf-409b-82e5-7a2286d1c24a
Public Version Date
September 03, 2020
Public Version Number
1
DI Record Publish Date
August 26, 2020
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 | 299 |