Duns Number:606719685
Catalog Number
CM9625
Brand Name
Drill Guide, Curved, SureLock® 2.2mm
Version/Model Number
CM9625
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
NBH
Product Code Name
Accessories, Arthroscopic
Public Device Record Key
9b0ac54f-f41e-43e9-8f0f-d4fd03bf948b
Public Version Date
August 23, 2022
Public Version Number
3
DI Record Publish Date
September 21, 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 | 166 |
2 | A medical device with a moderate to high risk that requires special controls. | 147 |