Duns Number:257315713
Device Description: SLIM EXTRACTOR FOR Ø2.0,2.6 & 3.2 mm RODS
Catalog Number
SLM-EXT123
Brand Name
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM
Version/Model Number
SLM-EXT123
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
-
Product Code
HWB
Product Code Name
EXTRACTOR
Public Device Record Key
1ad7f4d4-f7d7-485a-bfeb-d027e314c50a
Public Version Date
June 08, 2022
Public Version Number
1
DI Record Publish Date
May 31, 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 | 375 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 825 |