Duns Number:804185838
Device Description: Starr Frame Half Pin5mm, 250 x 50mm1 each
Catalog Number
SF-2250-5051
Brand Name
Starr Frame Half Pin
Version/Model Number
SF-2250-5051
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
f8db2d95-601b-4627-a8ac-fb16714f7b9d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 28, 2017
Package DI Number
00854226007042
Quantity per Package
10
Contains DI Package
00854226007035
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 |