Duns Number:047025993
Device Description: Full Stainless Steel Weighted Utensil Set (4pc)
Catalog Number
-
Brand Name
Vive
Version/Model Number
LVA1073STL
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IDL
Product Code Name
Microtome, Accessories
Public Device Record Key
0b0fcdf4-eac5-4405-9b9e-d2eda9b83221
Public Version Date
March 26, 2019
Public Version Number
1
DI Record Publish Date
March 18, 2019
Package DI Number
10818323021377
Quantity per Package
20
Contains DI Package
00818323021370
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 480 |
2 | A medical device with a moderate to high risk that requires special controls. | 87 |