Duns Number:927083808
Device Description: PILLAR AL TRIAL 26X20X14 12DEG 26MM X 20MMX 14MM,12DEG LORDOTIC
Catalog Number
-
Brand Name
CONSTRUX - PEEK VBR
Version/Model Number
48-1314
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"
Yes
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
LXH
Product Code Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Public Device Record Key
7b83005d-b381-4a2c-8181-bd05b7e37117
Public Version Date
February 24, 2020
Public Version Number
2
DI Record Publish Date
March 19, 2019
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 | 2497 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5891 |
| 3 | A medical device with high risk that requires premarket approval | 104 |