Duns Number:832696038
Device Description: STORZ SNGL-STEM CUTTING LOOP 24FR 5/BX
Catalog Number
013.10
Brand Name
V. Mueller
Version/Model Number
013.10
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 23, 2019
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
Yes
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
FAS
Product Code Name
ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
Public Device Record Key
a1675b69-c2cb-474e-b9b0-ca13d2275eb6
Public Version Date
December 11, 2019
Public Version Number
3
DI Record Publish Date
September 21, 2016
Package DI Number
20885403067379
Quantity per Package
5
Contains DI Package
10885403067372
Package Discontinue Date
January 23, 2019
Package Status
Not in Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 8016 |
2 | A medical device with a moderate to high risk that requires special controls. | 6223 |