Duns Number:124763728
Device Description: A metal device intended to be used to create internal threads in surgical site for implant A metal device intended to be used to create internal threads in surgical site for implants. They are available in narrow and regular platforms and different sizes.
Catalog Number
-
Brand Name
PUR® 3.2mm Tap
Version/Model Number
905256
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
K150968
Product Code
DZI
Product Code Name
Drill, Bone, Powered
Public Device Record Key
ec1a9223-a656-4314-b5f4-1d7de39aa97d
Public Version Date
June 09, 2020
Public Version Number
1
DI Record Publish Date
June 01, 2020
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1346 |