Duns Number:051957769
Device Description: MEMBERS MARK MPS 3X480ML
Catalog Number
94213
Brand Name
MEMBERS MARK
Version/Model Number
94213
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LPN
Product Code Name
Accessories, soft lens products
Public Device Record Key
f3ec3359-d89f-4616-9935-8cff690e939c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 25, 2016
Package DI Number
10078742168736
Quantity per Package
8
Contains DI Package
00078742168739
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 | 22 |
2 | A medical device with a moderate to high risk that requires special controls. | 76 |