Axial Handle 2901-082

GUDID 00192896115774

Axial Handle Angled With Spring And Ratchet For 3 Millimeter, 5 Millimeter, and 10 Millimeter Diameter Tube Shafts

SONTEC INSTRUMENTS, INC.

Laparoscopic surgery handle Laparoscopic surgery handle Laparoscopic surgery handle Laparoscopic surgery handle Laparoscopic surgery handle Laparoscopic surgery handle Laparoscopic surgery handle Laparoscopic surgery handle Laparoscopic surgery handle Laparoscopic surgery handle Laparoscopic surgery handle Laparoscopic surgery handle Laparoscopic surgery handle Laparoscopic surgery handle Laparoscopic surgery handle Laparoscopic surgery handle Laparoscopic surgery handle
Primary Device ID00192896115774
NIH Device Record Key1da02ddf-c168-4180-83ff-193783f2b9e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameAxial Handle
Version Model Number2901-082
Catalog Number2901-082
Company DUNS040729840
Company NameSONTEC INSTRUMENTS, INC.
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)821-7496
Emailinfo@sontecinstruments.com
Phone+1(800)821-7496
Emailinfo@sontecinstruments.com
Phone+1(800)821-7496
Emailinfo@sontecinstruments.com
Phone+1(800)821-7496
Emailinfo@sontecinstruments.com
Phone+1(800)821-7496
Emailinfo@sontecinstruments.com
Phone+1(800)821-7496
Emailinfo@sontecinstruments.com
Phone+1(800)821-7496
Emailinfo@sontecinstruments.com
Phone+1(800)821-7496
Emailinfo@sontecinstruments.com
Phone+1(800)821-7496
Emailinfo@sontecinstruments.com
Phone+1(800)821-7496
Emailinfo@sontecinstruments.com
Phone+1(800)821-7496
Emailinfo@sontecinstruments.com
Phone+1(800)821-7496
Emailinfo@sontecinstruments.com
Phone+1(800)821-7496
Emailinfo@sontecinstruments.com
Phone+1(800)821-7496
Emailinfo@sontecinstruments.com
Phone+1(800)821-7496
Emailinfo@sontecinstruments.com
Phone+1(800)821-7496
Emailinfo@sontecinstruments.com
Phone+1(800)821-7496
Emailinfo@sontecinstruments.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896115774 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, cutting & coagulation & accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115774]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-13
Device Publish Date2023-11-03

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