Duns Number:342228620
Catalog Number
-
Brand Name
Sterile Sheath for CONVIVO
Version/Model Number
302732-0530-000
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K181116,K181116,K181116
Product Code
GWG
Product Code Name
Endoscope, Neurological
Public Device Record Key
15858337-3164-47ce-8d22-aa62d2403dcc
Public Version Date
November 10, 2021
Public Version Number
2
DI Record Publish Date
December 13, 2019
Package DI Number
04049539103420
Quantity per Package
10
Contains DI Package
04049539103413
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |
| 3 | A medical device with high risk that requires premarket approval | 1 |