Duns Number:047025993
Device Description: Lift Sling with Opening
Catalog Number
-
Brand Name
Vive
Version/Model Number
LVA2057
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
IKX
Product Code Name
Aid, Transfer
Public Device Record Key
41a4f044-76fc-408e-b3ca-ddf78f2ded10
Public Version Date
October 16, 2020
Public Version Number
1
DI Record Publish Date
October 08, 2020
Package DI Number
10810041982466
Quantity per Package
20
Contains DI Package
00810041982469
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 |