Duns Number:089645059
Device Description: Small Frag Fastener Surgical Case including lid, upper instrument tray, lower instrument t Small Frag Fastener Surgical Case including lid, upper instrument tray, lower instrument tray, and screw Caddy
Catalog Number
A2200
Brand Name
OsteoCentric Trauma Small Frag Fastener Surgical Case
Version/Model Number
A2200
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
PXV
Product Code Name
General Purpose Instrument Tray
Public Device Record Key
5e9a24ab-e08a-427b-b4c2-da1955b7269e
Public Version Date
September 16, 2022
Public Version Number
5
DI Record Publish Date
October 09, 2019
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 | 60 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 846 |