Duns Number:025460908
Device Description: PROCESSING JARS 5ML 48/PK
Catalog Number
DYNJ50241C
Brand Name
Medline Industries, Inc.
Version/Model Number
DYNJ50241C
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)
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
88bb7ebc-3e15-4879-8ff9-3c2a58d36937
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
September 05, 2021
Package DI Number
40193489988186
Quantity per Package
4
Contains DI Package
10193489975079
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 | 38540 |
2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
3 | A medical device with high risk that requires premarket approval | 2 |
U | Unclassified | 7 |