Duns Number:109903521
Device Description: VERSABOND 40 GRAMS
Catalog Number
71271140
Brand Name
VERSABOND
Version/Model Number
71271140
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
K001160,K001160
Product Code
LOD
Product Code Name
BONE CEMENT
Public Device Record Key
39069196-ff80-49f5-a8d4-9fb32c7a57c4
Public Version Date
June 19, 2020
Public Version Number
5
DI Record Publish Date
August 29, 2015
Package DI Number
23596010411024
Quantity per Package
10
Contains DI Package
03596010411020
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |