Duns Number:800777117
Device Description: Lubricating jelly to lubricate the body orifices to facilitate the entry of medical and th Lubricating jelly to lubricate the body orifices to facilitate the entry of medical and therapeutic devices.
Catalog Number
T00137
Brand Name
PDI® Lubricating Jelly II
Version/Model Number
T00137
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 11, 2022
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
KMJ
Product Code Name
Lubricant, Patient
Public Device Record Key
ac1962dc-6cb6-4132-99f0-f4b2bb39bf07
Public Version Date
October 28, 2022
Public Version Number
2
DI Record Publish Date
October 09, 2020
Package DI Number
10310819000489
Quantity per Package
144
Contains DI Package
00310819000482
Package Discontinue Date
April 11, 2022
Package Status
Not 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 | 3 |
| U | Unclassified | 1 |