Duns Number:129278169
Catalog Number
24400
Brand Name
BIOMET® GROWTH CONTROL
Version/Model Number
24400
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
-
Product Code
GEN
Product Code Name
FORCEPS, GENERAL & PLASTIC SURGERY
Public Device Record Key
4f031123-683c-4585-9b20-4a2171b73f81
Public Version Date
June 11, 2018
Public Version Number
3
DI Record Publish Date
July 28, 2017
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 | 11962 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 28376 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 4 |