Catalog Number
-
Brand Name
IO-FLEX
Version/Model Number
iO-Wire
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K113533
Product Code
HAE
Product Code Name
Rongeur, Manual
Public Device Record Key
2aa1e101-6954-4a7c-9934-0bd849ff8e62
Public Version Date
September 20, 2021
Public Version Number
5
DI Record Publish Date
June 12, 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 | 1993 |
2 | A medical device with a moderate to high risk that requires special controls. | 3642 |
U | Unclassified | 15 |