Duns Number:184805166
Device Description: 1.8mm Expandable LeMaitre Valvulotome, 98 cm
Catalog Number
1000-90
Brand Name
Expandable LeMaitre Valvulotome
Version/Model Number
1000-90
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 30, 2019
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
85ebf68c-ea02-4d41-9f49-02944fd7d6ee
Public Version Date
April 21, 2021
Public Version Number
4
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 |