Duns Number:071595540
Device Description: 5.5 X 15MM GUARDSMAN INTERFERENCE SCREW
Catalog Number
255515
Brand Name
GUARDSMAN
Version/Model Number
255515
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 09, 2022
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
K933352
Product Code
HWC
Product Code Name
Screw, fixation, bone
Public Device Record Key
6a40805f-be95-4b4b-92b4-f98a8f18c7ca
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
October 24, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |