DEVICE: KY UltraGel (00067981087376)

Device Identifier (DI) Information

KY UltraGel
Personal Lubricant
In Commercial Distribution

RECKITT BENCKISER LLC
00067981087376
GS1

1
094405024 *Terms of Use
Personal Lubricant
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
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
Vaginal lubricant A non-sterile substance (e.g., a gel or jelly) designed to lubricate the vagina to facilitate entry of a gloved finger(s) or a device, e.g., a vaginal speculum, during a diagnostic or therapeutic treatment. This substance will be compatible to the sensitive mucous and tissue of this area. After application, this device cannot be reused.
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FDA Product Code

[?]
Product Code Product Code Name
NUC Lubricant, personal
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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 away from direct sunlight
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Clinically Relevant Size

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

db442366-be01-46e5-b8d6-67a355cc5cba
March 29, 2018
2
September 20, 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
10067981087373 6 00067981087376 In Commercial Distribution Case
20067981087370 4 10067981087373 In Commercial Distribution Case
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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: No Unit of Use DI Numbers Found 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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