Duns Number:315427286
Device Description: Titanium jacket crown post, Length 21 mm, ø 1.8 mm
Catalog Number
-
Brand Name
N.A.
Version/Model Number
204-221-00
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 11, 2017
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
-
Product Code
EBL
Product Code Name
PIN, RETENTIVE AND SPLINTING, AND ACCESSORY INSTRUMENTS
Public Device Record Key
c7f15e26-9527-496c-8a52-6243b795c6ba
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 15, 2016
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 | 2768 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1745 |