FDA UDI In Commercial Distribution 🇺🇸 United States

Extended UNI Handle

DI: 08022057015136 · Model: ICV1342 · CORCYM SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Extended UNI Handle
Primary DI
08022057015136
Version / Model
ICV1342
Company Name
CORCYM SRL
Labeler DUNS
441454802
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-04-01
Public Version
2
Public Version Date
2023-02-08
Public Version Status
Update
Public Device Record Key
efe10cf0-568d-44fc-bed1-d7e572517239

Device Characteristics

Single Use
No
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
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
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
DWS INSTRUMENTS, SURGICAL, CARDIOVASCULAR

GMDN Terms

Code Name
47683 Heart valve prosthesis sizer handle

Identifiers

Type ID
Primary 08022057015136