REUSABLE WIRE LOOP - REUSABLE SHORT TUNGSTEN CARBIDE WIRE SHAFT LOOP - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: REUSABLE SHORT TUNGSTEN CARBIDE WIRE SHAFT LOOP

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More Product Details

Catalog Number

ES23R

Brand Name

REUSABLE WIRE LOOP

Version/Model Number

ES23R

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 19, 2020

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

257aed63-b459-4947-9404-9dbcde937677

Public Version Date

October 20, 2020

Public Version Number

2

DI Record Publish Date

August 16, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SONTEC INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10108
2 A medical device with a moderate to high risk that requires special controls. 3414