Duns Number:262277122
Catalog Number
-
Brand Name
STA R Max® (with cap piercing option)
Version/Model Number
59027
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
K082675,K093001,K151867,K983460
Product Code
JPA
Product Code Name
SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES
Public Device Record Key
88533a1f-4c25-42b9-b2f0-8723bafad02a
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
October 30, 2018
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 | 4 |
2 | A medical device with a moderate to high risk that requires special controls. | 57 |