Duns Number:008018525
Device Description: DISCOVISC 1.0ML<USA
Catalog Number
-
Brand Name
DISCOVISC
Version/Model Number
8065183710
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"
Yes
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
LZP
Product Code Name
Aid, Surgical, Viscoelastic
Public Device Record Key
3766c46a-7e7f-494c-87a4-4c49edf194ec
Public Version Date
May 06, 2019
Public Version Number
4
DI Record Publish Date
March 31, 2015
Package DI Number
20380651837106
Quantity per Package
85
Contains DI Package
00380651837102
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 | 250 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 541 |
| 3 | A medical device with high risk that requires premarket approval | 6098 |