Duns Number:355280827
Device Description: LOVE-GRUENWALD STILLE RONGEUR 3x10 mm semi detachable 18 cm 7 in ceramo coated
Catalog Number
105-13931-18-C
Brand Name
STILLE Rongeurs
Version/Model Number
105-13931-18-C
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)
-
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
195f29cc-2fdb-4f54-89aa-8cba32750db8
Public Version Date
October 12, 2020
Public Version Number
1
DI Record Publish Date
October 04, 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 | 1073 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |