Duns Number:276593071
Device Description: Metal Tube 5mm Diameter WL 210mm for Sheath CEV8649C5 and Scissors Insert CEV8605GP (pk3)
Catalog Number
CEV8649GPU
Brand Name
MicroFrance®
Version/Model Number
CEV8649GPU
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
K080257,K080257
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
a91b9f77-8a69-425e-9c27-4e666607970f
Public Version Date
August 21, 2019
Public Version Number
2
DI Record Publish Date
February 20, 2019
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 | 1433 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 879 |