Duns Number:138041277
Device Description: Superior Mediolateral Plate, Lt, 8-Hole
Catalog Number
CPSMLTL-8
Brand Name
Clavicle Plates
Version/Model Number
CPSMLTL-8
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
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
K112509
Product Code
HRS
Product Code Name
Plate, fixation, bone
Public Device Record Key
49374bf9-09b8-49a9-8cc3-b4ce068c780b
Public Version Date
March 03, 2022
Public Version Number
1
DI Record Publish Date
February 23, 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 | 555 |
2 | A medical device with a moderate to high risk that requires special controls. | 1934 |