Duns Number:039981550
Device Description: CLED / Mueller Hinton, 15x100, Biplate, 10/pkFor the isolation, enumeration, and presumpti CLED / Mueller Hinton, 15x100, Biplate, 10/pkFor the isolation, enumeration, and presumptive identification of urinary pathogensSection I: CLED (Cystine Lactose Electrolyte Deficient) Section II: Mueller Hinton
Catalog Number
2051
Brand Name
N/A
Version/Model Number
2051
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 16, 2021
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JSI
Product Code Name
Culture Media, Selective And Differential
Public Device Record Key
d78e08b0-db0c-4fc6-b2fa-db781def4b29
Public Version Date
June 17, 2021
Public Version Number
2
DI Record Publish Date
May 27, 2020
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 |