DEVICE: Cora (00810042480568)

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Device Record History
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Device Identifier (DI) Information
Cora
02Tampons-105
In Commercial Distribution

Cora
00810042480568
GS1

16
080294990 *Terms of Use
Cora Tampons, DTC, App. Light 5/Reg. 6/Super 5
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
No
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 [?]
K191431 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
No Device Sizes
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Device Record Status
30204029-23f9-4005-bbd1-1f3d0fe83229
June 10, 2022
2
April 27, 2021
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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: 00850373007041 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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