Duns Number:006961700
Device Description: TARGET LUBE JELLY 4 OZ - (TGT-024-4OZ)
Catalog Number
-
Brand Name
Up&Up
Version/Model Number
245-03-0534
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 01, 2020
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
-
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
K070623,K070623
Product Code
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
2e7d61c6-9c53-4219-b4aa-3481e25e4380
Public Version Date
May 11, 2020
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
10894025001732
Quantity per Package
12
Contains DI Package
00894025001735
Package Discontinue Date
January 01, 2020
Package Status
Not in Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 52 |
| U | Unclassified | 12 |