FDA UDI Not in Commercial Distribution 🇺🇸 United States

FREEDOM SOLO

DI: 00896208000375 · Model: ART21SG · Corcym Canada Corp
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
FREEDOM SOLO
Primary DI
00896208000375
Version / Model
ART21SG
Company Name
Corcym Canada Corp
Labeler DUNS
204322622
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2014-09-19
Public Version
7
Public Version Date
2025-05-30
Public Version Status
Update
Public Device Record Key
a79324ce-f32a-4066-9e72-e16adfde09cb
Distribution End Date
2024-06-30

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 Safe
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
LWR heart-valve, non-allograft tissue

GMDN Terms

Code Name
60242 Aortic open-surgery heart valve bioprosthesis

Identifiers

Type ID
Primary 00896208000375