FDA UDI In Commercial Distribution 🇺🇸 United States

Memo 4D

DI: 08022057015419 · Model: 4DM · CORCYM SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Memo 4D
Primary DI
08022057015419
Version / Model
4DM
Company Name
CORCYM SRL
Labeler DUNS
441454802
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-05-21
Public Version
5
Public Version Date
2023-07-19
Public Version Status
Update
Public Device Record Key
c2dc774e-b917-4e47-9f43-ba62592bf4ed

Device Characteristics

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

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
KRH RING, ANNULOPLASTY

GMDN Terms

Code Name
66338 Mitral/tricuspid annuloplasty ring, open-surgery

Identifiers

Type ID
Primary 08022057015419

Premarket Submissions

Submission Number Supplement Number
K180411 000
K230318 000