MICTEC CLIP APPLICATOR

GUDID B09920932300

MICTEC CLIP APPLICATOR FOR TITANIUM CLIPS ROTATING WITH CLEANING FLUSH PORT MEDIUM TO LARGE

SONTEC INSTRUMENTS, INC.

Open-surgery ligation clip applier
Primary Device IDB09920932300
NIH Device Record Key20961606-b797-479d-9b76-726139617b4a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMICTEC CLIP APPLICATOR
Version Model Number20932-30
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896008694 [Primary]
HIBCCB09920932300 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B09920932300]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B09920932300]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B09920932300]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-08-21
Device Publish Date2018-08-24

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