Duns Number:007941230
Device Description: Jelly Lubricating 5 Gram Packet Single-Patient Use Sterile Not Made With Natural Rubber La Jelly Lubricating 5 Gram Packet Single-Patient Use Sterile Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
5GRAMLUB
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)
-
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
b21135b1-6c93-4f80-9cb0-7a1dcf0ac47a
Public Version Date
September 30, 2020
Public Version Number
1
DI Record Publish Date
September 22, 2020
Package DI Number
50885632104839
Quantity per Package
4
Contains DI Package
30885632104835
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |