Duns Number:803488357
Device Description: B-P SHOULDER HUMERAL STEM W/O HEAD W/ ULTRACOAT - 10 MM
Catalog Number
02-04-0210
Brand Name
B-P TOTAL SHOULDER SYSTEM
Version/Model Number
02-04-0210
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
K904880
Product Code
KWS
Product Code Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Public Device Record Key
0740d839-df8a-421d-ae94-7f28723df0a2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 17, 2015
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 565 |