Duns Number:315887799
Device Description: Step reamer TAA0940
Catalog Number
60001938
Brand Name
FITBONE®
Version/Model Number
STRE TAA0940
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
K203399
Product Code
LXH
Product Code Name
Orthopedic Manual Surgical Instrument
Public Device Record Key
948f8d37-3292-4ece-8635-f1a8600d665b
Public Version Date
April 26, 2021
Public Version Number
1
DI Record Publish Date
April 17, 2021
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 | 7 |
2 | A medical device with a moderate to high risk that requires special controls. | 178 |