DEVICE: DUREX Pleasure Pack Condom (00302340302197)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
Yes | |
No | |
Yes | |
No | |
Yes | |
Yes | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
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. |
Basic male condom, synthetic polymer | A sheath made from synthetic polymers (e.g., polyurethane, polyisoprene) 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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HIS | CONDOM |
MOL | Condom, synthetic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K020659 | 000 |
K072169 | 000 |
K902509 | 000 |
K980319 | 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
bcad3fdb-8c7a-48ab-bd44-8e3049d17b8a
December 13, 2018
4
September 20, 2016
December 13, 2018
4
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 |
---|---|---|---|---|---|
20302340302191 | 6 | 10302340302194 | In Commercial Distribution | Case | |
10302340302194 | 3 | 00302340302197 | In Commercial Distribution | Carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
40302340302195
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)756-5488
xxx@xxx.xxx
xxx@xxx.xxx