DEVICE: Trojan™ Premium Latex Condoms Her Pleasure™ Sensations Armor™ (00022600974529)

Device Identifier (DI) Information

Trojan™ Premium Latex Condoms Her Pleasure™ Sensations Armor™
00022600974529
In Commercial Distribution

CHURCH & DWIGHT CO., INC.
00022600974529
GS1

12
001211952 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Medicated male condom, Hevea-latex A medicated, 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 contains a pharmaceutical agent [e.g., spermicide (nonoxynol-9), numbing agent (benzocaine, lidocaine)] typically intended to prevent sperm motility or improve sexual experience. This device may be textured, flavoured or contain lubricants. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
HIS CONDOM
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K912901 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

4b79254a-82b0-4ab1-9f9b-006eeaeabb81
July 06, 2018
3
October 14, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 80022600974525 CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)833-9532
Consumer.Relations@churchdwight.com
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