Duns Number:813622313
Device Description: 90ML MIDSTREAM KITW/FUNNEL ST
Catalog Number
-
Brand Name
Sterile Specimen Container
Version/Model Number
070010
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 28, 2022
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
-
Product Code
FMH
Product Code Name
CONTAINER, SPECIMEN, STERILE
Public Device Record Key
766217d3-1a1a-4a16-8f72-1b26da432abe
Public Version Date
August 09, 2022
Public Version Number
2
DI Record Publish Date
September 09, 2018
Package DI Number
37503025060171
Quantity per Package
1
Contains DI Package
17503025060177
Package Discontinue Date
July 28, 2022
Package Status
Not in Commercial Distribution
Package Type
PACKAGE
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 10 |