Cora
| Catalog Number: | N/A |
|---|---|
| Company Name: | Cora |
| Device Combination Product: | N/A |
| Device Commercial Dsitribution End Date: | N/A |
| Device Commercial Dsitribution Status: | In Commercial Distribution |
| Device Count: | 1 |
| Device Description: | Cora Disc, DTC + Amazon |
| Device hctp: | N/A |
| Device kit: | N/A |
| Device Publish Date: | 2022-06-07 |
| Device Record Status: | Published |
| Direct Market Exempt: | N/A |
| Has Donation ID number? | N/A |
| DUNS Number: | 80294990 |
| Has Expiration Date? | N/A |
| Is Labelled as NRL: | N/A |
| Is Labelled As No NRL: | N/A |
| Has Lot Batch Number: | true |
| Has Manufacutring Date: | N/A |
| MRI Safety Status: | Labeling does not contain MRI Safety Information |
| Is OTC? | true |
| Is Devic Premarket Exempt: | true |
| Public Device Record Key: | 38c4f3c2-2e27-4513-b997-170ecaae19a6 |
| Public Version Date: | 2022-06-15 |
| Public Version Number: | 1 |
| Public Version Status: | New |
| Is Rx? | N/A |
| Has Serial Number? | N/A |
| Is Single Use: | N/A |
| Version Model Number: | 10Disc-008 |
| Adress: | N/A |
Storage Condition
Storage Handling Type
Storage Handling High
Storage Handling Low
Storage Handling Special Condition
N/A
N/A
N/A
N/A
GMDN Terms
GMDN Name
GMDN Term Definition
Menstrual cup, non-latex, reusable
A cup-like receptacle placed by the user into the vagina to collect blood and cellular debris discharges during menstruation and discharges outside of the monthly menses. It is a small, soft device made of a biocompatible synthetic material (e.g., silicone elastomer) and is typically removed from the vagina by pulling on a protruding stem; depending upon design, it may or may not touch the cervix. The device can function as an alternative to tampons. This is a reusable device.
Identifiers
Device ID
Device ID Type
Issuing Agency
Contains DI No
Pkg Qty
Pkg Discontinue dt
Pkg Status
Pkg Type
X0037EZAVV
Primary
ICCBBA
Sterilization
Is Device Sterile
Is Steriliztion Prior Use
Sterilization Method
false
false
Product Codes
Product Code
Product Code Name
HHE
Cup, Menstrual
Pre Market Submisison
Submission Number
Supplement Number
N/A
N/A