DEVICE: FRED'S SUPER DOLLAR (00084579128587)

Device Identifier (DI) Information

FRED'S SUPER DOLLAR
637149
In Commercial Distribution

FRED'S, INC.
00084579128587
GS1

1
005866116 *Terms of Use
FRD-091-5OZ FRED'S LUBRICATING LIQUID 5OZ
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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 [?]
K052974 000
No CLOSE

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
Total Volume: 5 Fluid Ounce
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Device Record Status

9b25474e-f978-4930-b1c1-a78c7200b412
July 06, 2018
3
September 30, 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

[?]
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
No
No CLOSE

Customer Contact

[?]
8003747417
JSTREET@FREDSINC.COM
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