Duns Number:030370299
Device Description: Firelands Hospital Single Shot Epidural Tray
Catalog Number
-
Brand Name
Integra®
Version/Model Number
3405183
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
-
Product Code Name
-
Public Device Record Key
b565e8e1-c33a-45fd-90c3-b5a427a29469
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
November 11, 2016
Package DI Number
30381780356077
Quantity per Package
10
Contains DI Package
10381780356073
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 |