Duns Number:342582423
Device Description: INSERT FOR MA-9, 48 MM
Catalog Number
MA-9R
Brand Name
BMT Medizintechnik GmbH
Version/Model Number
MA-9R
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"
Yes
For Single-Use
-
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
-
Product Code
EAX
Product Code Name
MIRROR, MOUTH
Public Device Record Key
0c86ed15-d874-494d-8057-20a93b2ddcec
Public Version Date
December 04, 2020
Public Version Number
2
DI Record Publish Date
May 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 | 2079 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |