FDA UDI In Commercial Distribution 🇺🇸 United States

Endovenous Radiofrequency Ablation (RFA) Catheter

DI: 00860036000548 · Model: VEN-7-60 · Vein360 LLC
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

Basic Information

Brand Name
Endovenous Radiofrequency Ablation (RFA) Catheter
Primary DI
00860036000548
Version / Model
VEN-7-60
Catalog Number
VEN-7-60
Company Name
Vein360 LLC
Labeler DUNS
080926907
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-10-26
Public Version
1
Public Version Date
2021-11-03
Public Version Status
New
Public Device Record Key
5cc718b7-54d4-4629-8eb1-3f6821150c93

Device Description

Endovenous Radiofrequency Ablation (RFA) Catheter 7-60

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
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
GEI Electrosurgical, Cutting & Coagulation & Accessories

GMDN Terms

Code Name
57972 Radio-frequency ablation system

Identifiers

Type ID
Package 10860036000545
Primary 00860036000548
Previous 08600360005107