FDA UDI In Commercial Distribution 🇺🇸 United States

Numeris Tethered Coagulation System with VisiTrax®

DI: 00818354015287 · Model: CSK-025 · ATRICURE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Numeris Tethered Coagulation System with VisiTrax®
Primary DI
00818354015287
Version / Model
CSK-025
Company Name
ATRICURE, INC.
Labeler DUNS
006133784
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-10-24
Public Version
5
Public Version Date
2022-06-10
Public Version Status
Update
Public Device Record Key
db0224d3-1872-432c-8ec1-65d85d96f021

Device Description

5cm Tethered Coagulation System

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
Yes
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
OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

GMDN Terms

Code Name
60784 Cardiac radio-frequency ablation system generator

Identifiers

Type ID
Primary 00818354015287

Customer Contacts

Phone
866-349-2342

Device Sizes

Type Value Unit Text
Length 5 Centimeter