FDA UDI Not in Commercial Distribution 🇺🇸 United States

Cora

DI: X002US3067 · Model: 10Disc-003 · Cora
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Cora
Primary DI
X002US3067
Version / Model
10Disc-003
Company Name
Cora
Labeler DUNS
080294990
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-08-03
Public Version
3
Public Version Date
2025-07-14
Public Version Status
Update
Public Device Record Key
2622d948-863e-4d58-bfd4-a8151b2b8e7d
Distribution End Date
2024-05-22

Device Description

Disc, Amazon in Tins

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
HHE Cup, Menstrual

GMDN Terms

Code Name
47728 Menstrual cup/disc, non-latex, reusable

Identifiers

Type ID
Primary X002US3067