DEVICE: DUREX Massage & Play - Intensify 2 in 1 Lubricant - Guarana (00302340876391)
Device Identifier (DI) Information
DUREX Massage & Play - Intensify 2 in 1 Lubricant - Guarana
Personal Lubricant
In Commercial Distribution
RB Health (us) LLC
Personal Lubricant
In Commercial Distribution
RB Health (us) LLC
Personal Lubricant
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
34131 | Vaginal lubricant |
A non-sterile substance (e.g., a gel or jelly) designed to lubricate the vagina to facilitate entry of a gloved finger(s) or a device, e.g., a vaginal speculum, during a diagnostic or therapeutic treatment. This substance will be compatible to the sensitive mucous and tissue of this area. 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 [?] |
---|---|
K063385 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store at room temperature and avoid excess heat |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
72a7b362-0352-4155-a220-4a383aeaadbc
October 24, 2019
5
September 20, 2016
October 24, 2019
5
September 20, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20302340876395 | 6 | 10302340876398 | In Commercial Distribution | Case | |
10302340876398 | 3 | 00302340876391 | In Commercial Distribution | Bottle |
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
[?]
+1(800)756-5488
xxx@xxx.xxx
xxx@xxx.xxx