Duns Number:079376107
Device Description: MODIFIED THAYER MARTIN
Catalog Number
1100
Brand Name
MODIFIED THAYER MARTIN
Version/Model Number
1100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K950196,K950196,K950196
Product Code
JTY
Product Code Name
CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA
Public Device Record Key
a9c997eb-fd1b-4ec7-8ac6-5c1c2ccd02ac
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
M20211002
Quantity per Package
10
Contains DI Package
M20211001
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box