Duns Number:030370299
Device Description: Pudendal Block Tray
Catalog Number
-
Brand Name
Integra®
Version/Model Number
3405426
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
K960100,K960100
Product Code
CAZ
Product Code Name
Anesthesia conduction kit
Public Device Record Key
c59d0185-c382-4b2c-8335-8cd7834f34f8
Public Version Date
December 12, 2019
Public Version Number
3
DI Record Publish Date
February 27, 2019
Package DI Number
30381780511469
Quantity per Package
10
Contains DI Package
10381780511465
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 |