Duns Number:536935331
Device Description: The drilling guide is used to guide the drill as well as to protect the soft tissues while The drilling guide is used to guide the drill as well as to protect the soft tissues while drilling the bone for the 4.0mm compression screws. This drilling guide shall be used with the internal protection sleeve referenced 119501ND inserted within it.
Catalog Number
-
Brand Name
I.CO.S®
Version/Model Number
119506ND
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
b26cb4fa-e8eb-44ca-8ad4-d81e49c12ebf
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 |