Duns Number:050410323
Device Description: BHS DEMO UNITBiomet EBI Bone Healing SystemDemonstration Unit Not For Human Use
Catalog Number
1068339
Brand Name
Biomet EBI Bone Healing System
Version/Model Number
1068339
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
P790002
Product Code
LOF
Product Code Name
Stimulator, Bone Growth, Non-Invasive
Public Device Record Key
81853697-d415-4aa2-a4f6-f7186d4d2aed
Public Version Date
March 10, 2022
Public Version Number
4
DI Record Publish Date
September 19, 2014
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |
| 3 | A medical device with high risk that requires premarket approval | 70 |