Duns Number:832637081
Device Description: 5.0MM SELF-DRILLING SCHANZ SCREW 35MM THRD/175MM/STERILE
Catalog Number
02170535S
Brand Name
NA
Version/Model Number
02.170.535S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K040701,K161417,K122455,K082650
Product Code
HWC
Product Code Name
Screw, fixation, bone
Public Device Record Key
298ebf24-1164-40cb-9a2b-937df57c5b05
Public Version Date
February 15, 2022
Public Version Number
1
DI Record Publish Date
February 07, 2022
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 | 1194 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4171 |
| 3 | A medical device with high risk that requires premarket approval | 30 |
| U | Unclassified | 1 |