Duns Number:849626338
Device Description: SERTER MMT-7512N IIN GENERIC 2L
Catalog Number
-
Brand Name
One-press Serter
Version/Model Number
MMT-7512N
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
-
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
P160017
Product Code
MDS
Product Code Name
Sensor, glucose, invasive
Public Device Record Key
b95058c6-5ec6-404e-92d4-c918cda06274
Public Version Date
May 25, 2020
Public Version Number
1
DI Record Publish Date
May 16, 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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 29 |
| 3 | A medical device with high risk that requires premarket approval | 1084 |