MICTEC NEEDLE HOLDER 27998-05

GUDID 00192896011137

MICTEC NEEDLE HOLDER TOP DUR STRAIGHT Y-GRIP WITH HEGAR RATCHET WITH CLEAN FLUSHING PORT

SONTEC INSTRUMENTS, INC.

Needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable
Primary Device ID00192896011137
NIH Device Record Keybdf17470-b2b7-4964-9125-6ba2bca03a08
Commercial Distribution StatusIn Commercial Distribution
Brand NameMICTEC NEEDLE HOLDER
Version Model Number27998-05
Catalog Number27998-05
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
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com

Device Dimensions

Outer Diameter2 Millimeter
Outer Diameter2 Millimeter
Length240 Millimeter
Outer Diameter2 Millimeter
Length240 Millimeter
Outer Diameter2 Millimeter
Length240 Millimeter
Outer Diameter2 Millimeter
Length240 Millimeter
Outer Diameter2 Millimeter
Length240 Millimeter
Outer Diameter2 Millimeter
Length240 Millimeter
Outer Diameter2 Millimeter
Length240 Millimeter
Outer Diameter2 Millimeter
Length240 Millimeter
Outer Diameter2 Millimeter
Length240 Millimeter
Outer Diameter2 Millimeter
Length240 Millimeter
Outer Diameter2 Millimeter
Length240 Millimeter
Outer Diameter2 Millimeter
Length240 Millimeter
Outer Diameter2 Millimeter
Length240 Millimeter
Outer Diameter2 Millimeter
Length240 Millimeter
Outer Diameter2 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896011137 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00192896011137]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896011137]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896011137]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896011137]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896011137]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896011137]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896011137]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896011137]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896011137]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896011137]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896011137]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896011137]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896011137]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896011137]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[00192896011137]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-17
Device Publish Date2018-08-15

On-Brand Devices [MICTEC NEEDLE HOLDER]

00192896011144MICTEC NEEDLE HOLDER TOP DUR STRAIGHT Y-GRIP WITH HEGAR RATCHET WITH CLEAN FLUSHING PORT
00192896011137MICTEC NEEDLE HOLDER TOP DUR STRAIGHT Y-GRIP WITH HEGAR RATCHET WITH CLEAN FLUSHING PORT
00192896009110MICTEC NEEDLE HOLDER TOP DUR STRAIGHT WITHOUT RATCHET
00192896009103MICTEC NEEDLE HOLDER TOP DUR CURVED WITH HEGAR RATCHET
00192896009097MICTEC NEEDLE HOLDER TOP DUR STRAIGHT WITH HEGAR RATCHET CLEAN FLUSHING PORT

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