Duns Number:355280827
Device Description: RASPATORY COBB STILLE 25 mm 28.5 cm 11.25 in
Catalog Number
111-22155-25
Brand Name
STILLE Raspatories
Version/Model Number
111-22155-25
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
HTR
Product Code Name
Rasp
Public Device Record Key
045c8c27-e5c2-4a7a-8961-3eb2f3d16cae
Public Version Date
December 04, 2020
Public Version Number
2
DI Record Publish Date
September 24, 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 |