DEVICE: 29V11 Femcare LLC (00860012328710)

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Device Record History
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Device Identifier (DI) Information
29V11 Femcare LLC
card board applicator, super plus, 12-15g absorbency
In Commercial Distribution

29V11 Femcare LLC
00860012328710
GS1

12
136033299 *Terms of Use
Cardboard applicator Super Plus 12-15g absorbency
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Device Characteristics
Labeling does not contain MRI Safety Information
No
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?
35694 Menstrual tampon, unscented
A non-deodorized plug made of cellulosic or synthetic material that is inserted into the vagina to absorb menstrual blood or other vaginal discharge. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HEB Tampon, Menstrual, Unscented
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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
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
54b309d6-1349-4762-a416-1f7a65ef9572
February 21, 2025
1
February 13, 2025
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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
00860012328789 12 00860012328710 In Commercial Distribution
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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: 08432984003845 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
9733806091
info@29v11femcare.com
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