Duns Number:239505063
Device Description: Tibbs Cannula Set of 3 Tibbs Cannula Set of 3
Catalog Number
S044
Brand Name
Single Use Surgical Professional
Version/Model Number
S044
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GAA
Product Code Name
Needle, Aspiration And Injection, Disposable
Public Device Record Key
8ddf0555-3945-4e77-a7c1-1e7a9510a845
Public Version Date
August 05, 2022
Public Version Number
3
DI Record Publish Date
August 19, 2016
Package DI Number
05055299100417
Quantity per Package
25
Contains DI Package
05055299101186
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |