Duns Number:373139427
Device Description: Guide and Bone model Shoulder Arthroplasty 2.5mm Center Pin
Catalog Number
225503003
Brand Name
TruMatch Personalised Solutions Shoulder System
Version/Model Number
225503003
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
-
Product Code
KWS
Product Code Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Public Device Record Key
d77e6469-262a-45e3-98f6-3a6f0719299b
Public Version Date
October 17, 2022
Public Version Number
5
DI Record Publish Date
May 14, 2018
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 | 91 |
2 | A medical device with a moderate to high risk that requires special controls. | 296 |