Duns Number:318034329
Device Description: The system Master-Pin-Control consist of Pins and neccessary accessories.The system contai The system Master-Pin-Control consist of Pins and neccessary accessories.The system contains 34 Pins.Pins are used for the fixation of membranes (resorbable membranes nonresorbable membranes) to the bone structure.They have a mini-thread and a hexalobular connection for a screwdriver.Pins are intended for single use only.The Pins consist of titanium alloy Grade 5 and are delivered non sterile.
Catalog Number
BMP00
Brand Name
Master-Pin-Control
Version/Model Number
BMP00
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
Yes
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
K130682,K130682
Product Code
DZL
Product Code Name
Screw, Fixation, Intraosseous
Public Device Record Key
c7eb46c8-ae69-4d81-8b91-704ad80b20b6
Public Version Date
February 20, 2019
Public Version Number
4
DI Record Publish Date
July 13, 2015
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 | 4140 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 237 |