DEVICE: FemCap (00863008000119)

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Device Identifier (DI) Information

FemCap
26 mm medium
70-399-26
FEMCAP, INC.
00863008000119
GS1
1
FemCap™ is indicated for use by women of child-bearing age who desire a barrier device to prevent or postpone pregnancy.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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
Contraceptive cervical cap, reusable A contraceptive device that is inserted into the cervix where it acts as a physical barrier to prevent semen from entering the uterus. It is typically a soft rubber cup with a round rim that is sized by a healthcare professional to fit snugly around the cervix. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
LLQ Cap, Cervical, Contraceptive
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: 26 mm
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Device Status

In Commercial Distribution
April 15, 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
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

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

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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858-481-8837
femcap@yahoo.com
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