Duns Number:067486548
Device Description: Gentle Gel Lubricating Gel- 20 ml sterile packet
Catalog Number
36-1500-20
Brand Name
Pharmaceutical Innovations
Version/Model Number
Gentle Gel Lubricating Gel
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MMS
Product Code Name
Lubricant, Vaginal, Patient
Public Device Record Key
d46837b2-8285-4b8a-a65c-da0efbac3e9e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
March 08, 2017
Package DI Number
10300361500209
Quantity per Package
25
Contains DI Package
00300361500202
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |