FDA UDI Not in Commercial Distribution 🇺🇸 United States

REUSABLE WIRE LOOP

DI: 00192896009387 · Model: ES23R · SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
REUSABLE WIRE LOOP
Primary DI
00192896009387
Version / Model
ES23R
Catalog Number
ES23R
Company Name
SONTEC INSTRUMENTS, INC.
Labeler DUNS
040729840
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-08-16
Public Version
2
Public Version Date
2020-10-20
Public Version Status
Update
Public Device Record Key
257aed63-b459-4947-9404-9dbcde937677
Distribution End Date
2020-10-19

Device Description

REUSABLE SHORT TUNGSTEN CARBIDE WIRE SHAFT LOOP

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

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]

Product Codes

Code Name
GEI Electrosurgical, Cutting & Coagulation & Accessories

GMDN Terms

Code Name
61876 Open-surgery electrosurgical electrode, monopolar, reusable

Identifiers

Type ID
Primary 00192896009387

Customer Contacts

Phone
800-821-7496

Device Sizes

Type Value Unit Text
Length .75 Inch