Duns Number:053950783
Device Description: VersaTie Band, 4.5mm Hook-Malleable End
Catalog Number
-
Brand Name
VersaTie
Version/Model Number
8450001
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
K161265
Product Code
OWI
Product Code Name
Bone fixation cerclage, sublaminar
Public Device Record Key
4fa47ac0-462f-48a1-8f8c-911bd8bc91af
Public Version Date
September 24, 2018
Public Version Number
4
DI Record Publish Date
June 14, 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 | 4207 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38751 |
| 3 | A medical device with high risk that requires premarket approval | 84 |
| U | Unclassified | 29 |