Duns Number:813622313
Device Description: 120ml/53mmSPC NO LBL,OR CAP,ST
Catalog Number
-
Brand Name
Sterile Specimen Container
Version/Model Number
070000
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
980752d9-08e3-4805-aff7-4f3da439e8b8
Public Version Date
August 09, 2022
Public Version Number
2
DI Record Publish Date
November 08, 2018
Package DI Number
37503025060133
Quantity per Package
100
Contains DI Package
17503025060139
Package Discontinue Date
July 28, 2022
Package Status
Not in Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 10 |