Duns Number:007198742
Device Description: ERTO-CF27 Rotating CF Obturator, 27Fr
Catalog Number
-
Brand Name
USA Elite System™ Rotating Continuous Flow Resectoscope Timberlake Ob
Version/Model Number
ERTO-CF27
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
FEC
Product Code Name
OBTURATOR, FOR ENDOSCOPE
Public Device Record Key
5b61808e-9ff3-417d-94e8-052eeb280bfe
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 14, 2016
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 | 899 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1586 |
| 3 | A medical device with high risk that requires premarket approval | 9 |
| U | Unclassified | 4 |