Duns Number:025460908
Device Description: NEW LONDON CYSTO
Catalog Number
DYNJ901819
Brand Name
Medline Industries, Inc.
Version/Model Number
DYNJ901819
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)
Yes
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
EYN
Product Code Name
TRAY, IRRIGATION, STERILE
Public Device Record Key
8a3e02c0-ee00-420a-8310-e0a572ab00f9
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
November 07, 2016
Package DI Number
40888277841797
Quantity per Package
4
Contains DI Package
10888277841796
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |