Duns Number:039981550
Device Description: MARTIN LEWIS w/ LINCOMYCIN, PP(Martin Lewis Agar with lincomycin, reduced vancomycin, coli MARTIN LEWIS w/ LINCOMYCIN, PP(Martin Lewis Agar with lincomycin, reduced vancomycin, colistin, amphotericin, and trimethoprim) For the selective isolation of Neisseria gonorrhoeae. Petri plate has a "pill pocket" receptacle for the addition of a CO2 tablet. 10 tablets and 10 ziplock.
Catalog Number
E31
Brand Name
NA
Version/Model Number
E31
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
K934331,K934331
Product Code
JTY
Product Code Name
Culture Media, For Isolation Of Pathogenic Neisseria
Public Device Record Key
ec9df328-2e78-4a34-8020-3b040a958245
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 01, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 132 |