Duns Number:536935331
Device Description: The internal protecting sleeve is used to protect the soft tissues while drilling the bone The internal protecting sleeve is used to protect the soft tissues while drilling the bone for the 6.5mm compression screws. This protecting sleeve shall be inserted within the external protection sleeve referenced 119552ND. The drilling guide referenced 119541ND shall be inserted within this internal protecting sleeve.
Catalog Number
-
Brand Name
I.CO.S®
Version/Model Number
119551ND
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
FZX
Product Code Name
Guide, surgical, instrument
Public Device Record Key
98e22138-f9e7-4ff5-9b8b-8f5b9ee6f165
Public Version Date
April 06, 2020
Public Version Number
4
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 |