Duns Number:804185838
Device Description: Starr Frame Half Pin, 375 mm6mm, 375 x 70mm1 each
Catalog Number
SF-2375-6071
Brand Name
Starr Frame Half Pin
Version/Model Number
SF-2375-6071
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K082017,K082017
Product Code
JDW
Product Code Name
Pin, Fixation, Threaded
Public Device Record Key
e615bd62-0d54-4561-9ff3-90335eff461f
Public Version Date
September 22, 2020
Public Version Number
1
DI Record Publish Date
September 14, 2020
Package DI Number
00854226007134
Quantity per Package
10
Contains DI Package
00854226007127
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelf carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 8 |
2 | A medical device with a moderate to high risk that requires special controls. | 3 |