Duns Number:315304071
Device Description: TELESCOPE DILATOR 12FR for nephrostomy, in particular for dilating transcutaneous punctur TELESCOPE DILATOR 12FR for nephrostomy, in particular for dilating transcutaneous punctures, TL 230mm, reusable
Catalog Number
8955.121
Brand Name
NA
Version/Model Number
8955121
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
KOE
Product Code Name
Dilator, urethral
Public Device Record Key
3ba903fe-c32f-4b1a-9b9e-6cae06c6fcb2
Public Version Date
March 08, 2022
Public Version Number
1
DI Record Publish Date
February 28, 2022
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 | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |