Duns Number:486711679
Device Description: PROTECTION SLEEVE W/ QC FEMORAL NECK SYSTEM
Catalog Number
SD03010502
Brand Name
NA
Version/Model Number
SD03.010.502
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
K033618
Product Code
HSB
Product Code Name
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Public Device Record Key
61441df6-e209-48d3-aa7e-a3a2a92de124
Public Version Date
May 02, 2022
Public Version Number
2
DI Record Publish Date
October 29, 2020
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 | 8630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16671 |
| U | Unclassified | 2 |