Duns Number:105722131
Device Description: Stainless steel rod with specific sized ends (12 and 13 mm) for aiding in the measurement Stainless steel rod with specific sized ends (12 and 13 mm) for aiding in the measurement of soft tissue defects.
Catalog Number
BAR-DMT-12X13
Brand Name
Defect Measurement Tool (12/13mm)
Version/Model Number
400213
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
-
Product Code Name
-
Public Device Record Key
1b987d17-b961-4ea8-a4ef-1720803bd972
Public Version Date
February 12, 2020
Public Version Number
1
DI Record Publish Date
February 04, 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 | 3 |
| 3 | A medical device with high risk that requires premarket approval | 2 |