Duns Number:316153956
Device Description: ORTHOLOCK(R) EX-PIN 3 MM X 110 MM
Catalog Number
6007-103-110
Brand Name
NA
Version/Model Number
6007-103-110
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
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
-
Product Code
HAW
Product Code Name
Neurological stereotaxic Instrument
Public Device Record Key
23d50f36-8bc8-4f67-a40e-7e3d749db980
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 21, 2016
Package DI Number
54546540503225
Quantity per Package
5
Contains DI Package
34546540503221
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 777 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2520 |