Duns Number:079881212
Device Description: SHORT PRX HUM REAMGUIDE 8 145
Catalog Number
-
Brand Name
GLOBAL UNITE™ Short Stem Instrumentation
Version/Model Number
230774800
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
K211553
Product Code
HSD
Product Code Name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Public Device Record Key
f4bccb48-f066-4198-b9b8-7ce0a25aa4ad
Public Version Date
September 09, 2021
Public Version Number
1
DI Record Publish Date
September 01, 2021
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 | 201 |
2 | A medical device with a moderate to high risk that requires special controls. | 35 |