Duns Number:109903521
Device Description: ILIZAROV SPONGE
Catalog Number
102140
Brand Name
ILIZAROV
Version/Model Number
102140
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
K994143,K994143,K994143
Product Code
JDW
Product Code Name
PIN, FIXATION, THREADED
Public Device Record Key
64d3e0f9-8283-4506-af42-013e96d354e3
Public Version Date
April 22, 2022
Public Version Number
5
DI Record Publish Date
August 29, 2015
Package DI Number
33596010031328
Quantity per Package
5
Contains DI Package
23596010031321
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 |