AutoSonix 012026

GUDID 20884521058276

Shears

Covidien LP

Soft-tissue ultrasonic surgical system
Primary Device ID20884521058276
NIH Device Record Key39eb3790-d1b3-4144-ba0b-95401b8b808c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutoSonix
Version Model Number012026
Catalog Number012026
Company DUNS058614483
Company NameCovidien LP
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 Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Device Dimensions

Device Size Text, specify0
Outer Diameter5 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Device Size Text, specify0
Outer Diameter5 Millimeter
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521058279 [Primary]
GS120884521058276 [Package]
Contains: 10884521058279
Package: CASE [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFLInstrument, ultrasonic surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-04-11
Device Publish Date2018-08-18

On-Brand Devices [AutoSonix]

20884521058313Hook Probe
20884521058306Shears
20884521058276Shears
10884521058194Transducer
10884521058187Transducer Cable
20884521058344Hook Probe
10884521058330Adapter Box
10884521058231Silencer Plug
20884521058160Shears
10884521058200Cart

Trademark Results [AutoSonix]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AUTOSONIX
AUTOSONIX
86117298 4514798 Live/Registered
Covidien LP
2013-11-13
AUTOSONIX
AUTOSONIX
75378993 2279945 Live/Registered
COVIDIEN LP
1997-10-24

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