Duns Number:025460908
Device Description: ST LUKES EYE PACK
Catalog Number
DYNJ54152B
Brand Name
Medline Industries, Inc.
Version/Model Number
DYNJ54152B
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OJK
Product Code Name
Eye tray
Public Device Record Key
e4719749-fe0a-42f2-8f89-9a4c83a27245
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
August 23, 2021
Package DI Number
40193489765428
Quantity per Package
6
Contains DI Package
10193489765427
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 |