Duns Number:879057065
Device Description: ID Glide is a water based personal lubricant, and is compatible with Latex & Polyurethane ID Glide is a water based personal lubricant, and is compatible with Latex & Polyurethane Condoms.
Catalog Number
IDDGLP03
Brand Name
ID Glide
Version/Model Number
ID Glide 3 ml Pillow
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
K051295,K051295,K051295,K051295
Product Code
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
d428841c-a468-4d24-881c-359581f4b898
Public Version Date
August 07, 2020
Public Version Number
5
DI Record Publish Date
January 23, 2017
Package DI Number
50761236109480
Quantity per Package
1000
Contains DI Package
00761236109416
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 56 |