DEVICE: Durex PleasureMax Condom (00302340301916)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
Yes | |
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? |
---|---|---|---|---|
45138 | Basic male condom, Hevea-latex |
A Hevea-latex rubber sheath intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract and/or prevent the transmission of sexually transmitted infections (STI). It may be textured, flavoured or contain lubricants. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HIS | CONDOM |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K040185 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
3805cf3e-ef0c-4057-b1dc-2efe2e25030b
December 13, 2018
4
February 14, 2017
December 13, 2018
4
February 14, 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 |
---|---|---|---|---|---|
10302340301913 | 1000 | 00302340301916 | In Commercial Distribution | Carton |
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