Duns Number:536935331
Device Description: The internal extractor, with a trocar tip and a three 2.6mm/120° flat pan attachment, is i The internal extractor, with a trocar tip and a three 2.6mm/120° flat pan attachment, is inserted into the 6.5mm head screw in order to remove the implanted screw.
Catalog Number
-
Brand Name
I.CO.S®
Version/Model Number
119592ND
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
HWB
Product Code Name
EXTRACTOR
Public Device Record Key
356d35ee-151f-489a-921a-4a45019f2da3
Public Version Date
February 21, 2020
Public Version Number
6
DI Record Publish Date
May 26, 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 | 388 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 235 |