Duns Number:030370299
Device Description: NERVE BLOCK TRAY
Catalog Number
-
Brand Name
Integra®
Version/Model Number
SS3114-01
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
-
Product Code Name
-
Public Device Record Key
69bac90b-f8c7-4fe1-a3ba-3cc73991942b
Public Version Date
December 12, 2019
Public Version Number
3
DI Record Publish Date
September 30, 2016
Package DI Number
30381780265003
Quantity per Package
10
Contains DI Package
10381780265009
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 261 |