DEVICE: Cora (00810042482425)

Notice: Any discrepancies with this record compared to the label?
If so, send a picture of the label to GUDIDSupport@fda.hhs.gov.

Device Identifier (DI) Information

Cora
02Tampons-110
In Commercial Distribution

Cora
00810042482425
GS1

32
080294990 *Terms of Use
100% Organic Cotton Tampons, Retail, Digital AF, Reg/Super/Super+ 32
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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

7690f5b1-40ee-47c2-bd68-42f2559605e0
January 29, 2026
1
January 21, 2026
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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
20810042482429 3 00810042482425 In Commercial Distribution MASTER CARTON
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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
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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