Duns Number:096372255
Device Description: SPECIMEN CUP W/LID
Catalog Number
31-111
Brand Name
DeRoyal
Version/Model Number
31-111
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NNI
Product Code Name
CONTAINER, SPECIMEN, NON-STERILE
Public Device Record Key
814f9e6e-32de-4897-be09-7cfec281717e
Public Version Date
July 22, 2021
Public Version Number
2
DI Record Publish Date
June 30, 2021
Package DI Number
50749756027613
Quantity per Package
50
Contains DI Package
00749756027618
Package Discontinue Date
-
Package Status
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 | 7041 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4913 |
| U | Unclassified | 3 |