Duns Number:838734093
Device Description: BioMesh® Bender
Catalog Number
AMB3-30
Brand Name
Bioplate®
Version/Model Number
AMB3-30
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HAO
Product Code Name
Instrument, Surgical, Non-Powered
Public Device Record Key
c020a6ae-e81c-4cd5-89d4-52b572291992
Public Version Date
February 23, 2022
Public Version Number
2
DI Record Publish Date
October 29, 2018
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 | 198 |
2 | A medical device with a moderate to high risk that requires special controls. | 506 |