Canady Hybrid Plasma Scalpel

GUDID B413AW4225520

The Canady Hybrid Plasma Scalpel is an electrosurgical plasma scalpel that uses an 35mm non-bendable tip. The electrosurgical plasma scalpel is used to simultaneously cut and coagulate biological tissue.

US MEDICAL INNOVATIONS, LLC

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Primary Device IDB413AW4225520
NIH Device Record Key1093597a-c34f-4212-9bd9-d4dc5b2fa5ae
Commercial Distribution Discontinuation2020-03-23
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCanady Hybrid Plasma Scalpel
Version Model NumberAW-422552
Company DUNS961656951
Company NameUS MEDICAL INNOVATIONS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB413AW4225520 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[B413AW4225520]

Ethylene Oxide


[B413AW4225520]

Ethylene Oxide


[B413AW4225520]

Ethylene Oxide


[B413AW4225520]

Ethylene Oxide


[B413AW4225520]

Ethylene Oxide


[B413AW4225520]

Ethylene Oxide


[B413AW4225520]

Ethylene Oxide


[B413AW4225520]

Ethylene Oxide


[B413AW4225520]

Ethylene Oxide


[B413AW4225520]

Ethylene Oxide


[B413AW4225520]

Ethylene Oxide


[B413AW4225520]

Ethylene Oxide


[B413AW4225520]

Ethylene Oxide


[B413AW4225520]

Ethylene Oxide


[B413AW4225520]

Ethylene Oxide


[B413AW4225520]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-03-23
Device Publish Date2018-03-05

On-Brand Devices [Canady Hybrid Plasma Scalpel]

B413AW4225540The Canady Hybrid Plasma Scalpel is an electrosurgical plasma scalpel that uses an 85mm non-bend
B413AW4225520The Canady Hybrid Plasma Scalpel is an electrosurgical plasma scalpel that uses an 35mm non-bend

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