NA - RF PROBE PARAGON T2 W/INTEGRATED CABLE - STERILMED, INC.

Duns Number:175899459

Device Description: RF PROBE PARAGON T2 W/INTEGRATED CABLE

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More Product Details

Catalog Number

ARTAC5531-01

Brand Name

NA

Version/Model Number

ARTAC5531-01

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

K012679

Product Code Details

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Record Status

Public Device Record Key

d719b334-60f8-4ccb-ba5c-333b155a944f

Public Version Date

August 14, 2019

Public Version Number

4

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STERILMED, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2763
2 A medical device with a moderate to high risk that requires special controls. 1372
U Unclassified 20