FDA UDI Not in Commercial Distribution 🇺🇸 United States

Mirror™

DI: M543100415 · Model: 100415 · CAYENNE MEDICAL, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Mirror™
Primary DI
M543100415
Version / Model
100415
Company Name
CAYENNE MEDICAL, INC.
Labeler DUNS
606719685
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2015-10-23
Public Version
5
Public Version Date
2023-12-21
Public Version Status
Update
Public Device Record Key
44aba81d-5762-41b2-92c9-14cfdd708dce
Distribution End Date
2021-09-14

Device Description

Two post femoral symmetric (Size 42mm)

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
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

GMDN Terms

Code Name
33369 Uncoated unicondylar knee femur prosthesis

Identifiers

Type ID
Primary M543100415