Duns Number:153909531
Device Description: Restore is a patient lubricant intended for medical purposes that is used to lubricate a b Restore is a patient lubricant intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
Catalog Number
900300
Brand Name
Restore Moisturizing Vaginal Gel
Version/Model Number
2 oz
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KMJ
Product Code Name
Lubricant, Patient
Public Device Record Key
14833997-7a18-4fc9-8c56-edfc23f69827
Public Version Date
June 22, 2021
Public Version Number
2
DI Record Publish Date
February 16, 2021
Package DI Number
30850014621477
Quantity per Package
24
Contains DI Package
00850014621476
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |