FDA UDI In Commercial Distribution 🇺🇸 United States

VOYANT® Electrosurgical Generator

DI: 00607915137601 · Model: EA020 · APPLIED MEDICAL RESOURCES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
VOYANT® Electrosurgical Generator
Primary DI
00607915137601
Version / Model
EA020
Company Name
APPLIED MEDICAL RESOURCES CORPORATION
Labeler DUNS
187129135
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-01-28
Public Version
2
Public Version Date
2023-04-04
Public Version Status
Update
Public Device Record Key
e22a7ebc-e064-4a80-b63d-bad167d3357e

Device Description

Electrosurgical Generator

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
No
Has Serial Number
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
GEI Electrosurgical, Cutting & Coagulation & Accessories

GMDN Terms

Code Name
11490 Electrosurgical system generator

Identifiers

Type ID
Primary 00607915137601

Customer Contacts

Phone
19497138300