DEVICE: pjur Backdoor water-based (00827160112165)
Device Identifier (DI) Information
pjur Backdoor water-based
pjur backdoor waterbased 100 ml - USA
In Commercial Distribution
12840-02
Pjur Group Luxembourg SA
pjur backdoor waterbased 100 ml - USA
In Commercial Distribution
12840-02
Pjur Group Luxembourg SA
Water-based Personal Lubricant with Hyaluron
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
Yes | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
60412 | Sexual lubricant |
A substance (e.g., a gel or jelly) intended to be applied to the penis, vagina and/or anus for lubrication during sexual intercourse or to be used with a sexual vibrator. This substance contains no pharmaceutical ingredients. After application, this device cannot be reused.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NUC | Lubricant, Personal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K010199 | 000 |
K200527 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
e65f2c3b-de9e-4e92-9354-cd46842c7d6f
August 31, 2022
7
January 25, 2017
August 31, 2022
7
January 25, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
40827160112163 | 12 | 10827160112162 | In Commercial Distribution | case | |
10827160112162 | 12 | 00827160112165 | In Commercial Distribution | pack |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined