Duns Number:039981550
Device Description: Middlebrook 7H11 Thin Pour, for microscopic examination, 10x100mm Space Saver plate, order Middlebrook 7H11 Thin Pour, for microscopic examination, 10x100mm Space Saver plate, order by the package of 15For the isolation and detection of mycobacteria using the microcolony method. Thin pour plate for microscopic examination. Use with MycoSeals (cat. no. SS9225)
Catalog Number
SP57
Brand Name
N/A
Version/Model Number
SP57
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KZI
Product Code Name
Culture Media, Enriched
Public Device Record Key
6c827176-63e1-4471-b102-be8e3be85637
Public Version Date
June 15, 2020
Public Version Number
1
DI Record Publish Date
June 05, 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 |