Duns Number:079767953
Device Description: 150 4oz Specimen Cups with Screw On Lids
Catalog Number
vk150nssc
Brand Name
Avaline Medical NJ LLC
Version/Model Number
vk150nssc
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
NNI
Product Code Name
CONTAINER, SPECIMEN, NON-STERILE
Public Device Record Key
809a470d-1956-4925-bb92-da38fbe16f54
Public Version Date
April 23, 2021
Public Version Number
1
DI Record Publish Date
April 15, 2021
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 | 263 |