Duns Number:060783407
Device Description: Stratum Reduced Size T Plate - 8 Hole
Catalog Number
-
Brand Name
Stratum RS
Version/Model Number
STRM-T8-RS
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
K200785
Product Code
HRS
Product Code Name
Plate, Fixation, Bone
Public Device Record Key
1926833f-6630-40f4-b652-7a640c2c37fc
Public Version Date
September 23, 2022
Public Version Number
2
DI Record Publish Date
November 10, 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 | 152 |
2 | A medical device with a moderate to high risk that requires special controls. | 560 |