Duns Number:184805166
Device Description: 2.0mm Over-the-Wire LeMaitre Valvulotome, 100 cm
Catalog Number
1005-00
Brand Name
Over-the-Wire LeMaitre Valvulotome
Version/Model Number
1005-00
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
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
MGZ
Product Code Name
Valvulotome
Public Device Record Key
182804dd-596d-4de1-b5ca-8f8e3816d83d
Public Version Date
April 21, 2021
Public Version Number
3
DI Record Publish Date
June 30, 2015
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 453 |
| 3 | A medical device with high risk that requires premarket approval | 22 |