Duns Number:047486041
Device Description: Instrument, Caddy Body 1-3 Level Plate, Anterior Cervical Plating System (ACP)
Catalog Number
-
Brand Name
tangis
Version/Model Number
ACP-CDY-101
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
LRP
Product Code Name
Tray, Surgical
Public Device Record Key
6ac069a3-ef58-4d05-b00e-77a5cc8d8717
Public Version Date
January 20, 2020
Public Version Number
4
DI Record Publish Date
February 28, 2017
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 | 461 |
2 | A medical device with a moderate to high risk that requires special controls. | 1046 |