DEVICE: DUREX Pleasure Ring (00067981957525)

Device Identifier (DI) Information

DUREX Pleasure Ring
Penile Rigidity Ring
In Commercial Distribution

RECKITT BENCKISER LLC
00067981957525
GS1

1
094405024 *Terms of Use
Penile Rigidity Ring
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Penile ring A device intended to be applied externally to the penis for the management of erectile dysfunction (ED) (commonly known as impotence) by enabling the maintenance of a penile erection adequate for vaginal intercourse. It is typically designed as a flexible rubber loop that is placed on the penis (i.e., around its base) to restrict the flow of venous blood leaving the penis during an erection. This device can be used alone or with a penile vacuum pump. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
LKY Device, external penile rigidity
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

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Storage and Handling
Special Storage Condition, Specify: Store in a cool dry place away from direct sunlight and corrosive chemicals and avoid extremes of heat and cold
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

8c393e97-3b2d-45eb-a644-80eb0f293b18
March 29, 2018
2
September 20, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10067981957522 4 00067981957525 In Commercial Distribution Case
20067981957529 12 10067981957522 In Commercial Distribution Case
30067981957526 3 20067981957529 In Commercial Distribution case
40067981957523 8 30067981957526 In Commercial Distribution case
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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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

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Yes
No
Yes
No
No CLOSE

Customer Contact

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