Sustainable Technologies - Serfas Energy 90-S Accelerator RF Ablation Probe - Provision

Duns Number:016889401

Device Description: Serfas Energy 90-S Accelerator RF Ablation Probe

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More Product Details

Catalog Number

ST279-351-400

Brand Name

Sustainable Technologies

Version/Model Number

ST279-351-400

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

Yes

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

K173740

Product Code Details

Product Code

NUJ

Product Code Name

Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

Device Record Status

Public Device Record Key

e00b3b2d-ca23-45be-bf15-618251adb206

Public Version Date

May 24, 2021

Public Version Number

3

DI Record Publish Date

July 02, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PROVISION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3993
2 A medical device with a moderate to high risk that requires special controls. 1216