Hobbs Medical TouchSoft Coagulator - An assembly of devices that uses radio-frequency - HOBBS MEDICAL, INC.

Duns Number:076769355

Device Description: An assembly of devices that uses radio-frequency (RF) alternating current to develop heat An assembly of devices that uses radio-frequency (RF) alternating current to develop heat directly within soft-tissue cells (thermodynamic) for cutting and coagulating tissue within a shield of argon (Ar) gas during surgery. It typically includes a generator, a single-use/reusable electrode handpiece with monopolar electrodes, connecting cables, foot-switch, and an argon gas supply system [housed in a separate trolley (cart) or incorporated into the system generator]. The current forms an ionized channel or arc within the argon shield which lessens the charring of tissue and provides rapid, uniform coagulation over large bleeding surfaces (e.g., capillary beds).

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More Product Details

Catalog Number

4581-U

Brand Name

Hobbs Medical TouchSoft Coagulator

Version/Model Number

G1120040

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

KNS

Product Code Name

Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Device Record Status

Public Device Record Key

7e99beba-c485-46b2-a500-4b4dca609f21

Public Version Date

July 29, 2021

Public Version Number

3

DI Record Publish Date

April 07, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HOBBS MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 196