Duns Number:015272206
Device Description: Drill sleeve, single-ended, 4 1/2'', 40.0mm long tip, for 3.2mm diameter drill bits, also Drill sleeve, single-ended, 4 1/2'', 40.0mm long tip, for 3.2mm diameter drill bits, also for round hole and semi-tublar plates
Catalog Number
45-968
Brand Name
Ambler Surgical
Version/Model Number
Drill sleeve
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
9ab5562d-37c3-4f80-a30a-caeb295a2092
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 |