FDA UDI In Commercial Distribution 🇺🇸 United States

VESALIUS STERILE single-use GLADIO wire electrode for microsurgery

DI: 08034055297926 · Model: STERILE, lf=3mm L=100mm GLADIO · TELEA ELECTRONIC ENGEENERING SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
VESALIUS STERILE single-use GLADIO wire electrode for microsurgery
Primary DI
08034055297926
Version / Model
STERILE, lf=3mm L=100mm GLADIO
Catalog Number
2602058
Company Name
TELEA ELECTRONIC ENGEENERING SRL
Labeler DUNS
435331459
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-24
Public Version
3
Public Version Date
2019-02-07
Public Version Status
Update
Public Device Record Key
f6c61087-5e19-4e09-aa23-90e9925ecee3

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
GEI Electrosurgical, Cutting & Coagulation & Accessories

GMDN Terms

Code Name
61874 Open-surgery electrosurgical electrode, monopolar, single-use

Identifiers

Type ID
Package 8034055298084
Primary 08034055297926