DEVICE: DUREX Extra Sensitive Stimulating Condom (00067981160475)

Device Identifier (DI) Information

DUREX Extra Sensitive Stimulating Condom
Condom
In Commercial Distribution

RB Health (us) LLC
00067981160475
GS1

12
081049410 *Terms of Use
Condom
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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
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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 [?]
K040185 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat
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Clinically Relevant Size

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

c73a3a7a-5cf4-48fe-90f3-c7ecd8eac52c
April 17, 2020
1
April 09, 2020
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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
20067981160479 6 10067981160472 In Commercial Distribution Case
10067981160472 3 00067981160475 In Commercial Distribution Carton
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Secondary DI

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

[?]
Unit of Use DI Number: 40067981160473 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(800)756-5488
xxx@xxx.xxx
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