Duns Number:015272206
Device Description: Universal drill guide, double-ended, for 2.5mm diameter drill bits, also for 3.5mm diamete Universal drill guide, double-ended, for 2.5mm diameter drill bits, also for 3.5mm diameter cotrical screws and 3.5mm diameter malleolar shaft screws, can be used as a neutral/load drill guide
Catalog Number
45-975
Brand Name
Ambler Surgical
Version/Model Number
Universal drill guide
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
-
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
d07636f7-58a3-4668-9f98-ba1f72965a6f
Public Version Date
January 12, 2021
Public Version Number
1
DI Record Publish Date
January 04, 2021
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 | 14984 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3118 |