FDA UDI In Commercial Distribution 🇺🇸 United States

Voss Non-Sterile Coronary Bypass Graft Marker

DI: 00811304020072 · Model: 40149-NS · VM CARDIO VASCULAR, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Voss Non-Sterile Coronary Bypass Graft Marker
Primary DI
00811304020072
Version / Model
40149-NS
Company Name
VM CARDIO VASCULAR, INC.
Labeler DUNS
799240457
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-01-05
Public Version
4
Public Version Date
2021-02-05
Public Version Status
Update
Public Device Record Key
37a9a093-426f-4c19-b44c-ac8d72bb1310

Device Description

Coronary Bypass Graft Marker-Non-sterile

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
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Ethylene Oxide

Product Codes

Code Name
KPK Marker, Ostia, Aorto-Saphenous Vein

GMDN Terms

Code Name
60867 Polymeric coronary bypass marker

Identifiers

Type ID
Primary 00811304020072

Premarket Submissions

Submission Number Supplement Number
K895369 000