Duns Number:187502109
Device Description: TAP, 10MM X 28MM BIOABSORBABLE ACL SCREW
Catalog Number
234-010-076
Brand Name
NA
Version/Model Number
234-010-076
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 27, 2015
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
HWX
Product Code Name
TAP, BONE
Public Device Record Key
b00799ac-6099-4eba-8af1-5e3bf844082f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 31, 2015
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 | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |