Duns Number:017246562
Device Description: KIDNEY RETRIEVAL
Catalog Number
DYNDJ1079
Brand Name
MEDLINE
Version/Model Number
DYNDJ1079
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
FMH
Product Code Name
CONTAINER, SPECIMEN, STERILE
Public Device Record Key
30ac4a8d-f118-422c-8e8e-da81d24087e3
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
April 13, 2020
Package DI Number
20193489196808
Quantity per Package
30
Contains DI Package
10193489196801
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 | 6043 |
2 | A medical device with a moderate to high risk that requires special controls. | 4077 |
U | Unclassified | 1 |