Duns Number:315018218
Device Description: MIASPAS MINI-TTA Rongeur, 30 °, upwards cutting, working length: 250 mm (9 3/4), toothed, MIASPAS MINI-TTA Rongeur, 30 °, upwards cutting, working length: 250 mm (9 3/4), toothed, jaw length: 14 mm, width: 5 mm
Catalog Number
FF579R
Brand Name
MIASPAS MINI-TTA
Version/Model Number
FF579R
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
-
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
HTX
Product Code Name
RONGEUR
Public Device Record Key
c79f59d3-fadf-4833-8fc6-bb3dc058adf5
Public Version Date
June 25, 2020
Public Version Number
1
DI Record Publish Date
June 17, 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 | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |