Duns Number:400744553
Catalog Number
-
Brand Name
pjur Mini Collection - 4 x 10 ml - USA - not for sale
Version/Model Number
pjur Mini Collection - 4 x 10 ml - USA - not for sale
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
K010199,K133233,K141913,K010199,K133233,K141913,K010199,K133233,K141913
Product Code
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
0d5a6967-7d87-4c7f-95a4-a4dd81013e1d
Public Version Date
August 07, 2020
Public Version Number
2
DI Record Publish Date
June 18, 2020
Package DI Number
10827160114296
Quantity per Package
6
Contains DI Package
00827160114299
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 58 |