Micasept Top Dur Needle Holder 20918-06

GUDID 00192896121607

Micasept Top Dur Needle Holder With Hegar Ratchet Curved 4.5 Millimeter Tip

SONTEC INSTRUMENTS, INC.

Suturing needle holder, reusable
Primary Device ID00192896121607
NIH Device Record Keyddbba862-6938-4ea2-8a29-819c481a7fe5
Commercial Distribution StatusIn Commercial Distribution
Brand NameMicasept Top Dur Needle Holder
Version Model Number20918-06
Catalog Number20918-06
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

Device Dimensions

Length300 Millimeter
Length300 Millimeter
Length300 Millimeter
Length300 Millimeter
Length300 Millimeter
Length300 Millimeter
Length300 Millimeter
Length300 Millimeter
Length300 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896121607 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, general & plastic surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00192896121607]

Dry Heat Sterilization


[00192896121607]

Dry Heat Sterilization


[00192896121607]

Dry Heat Sterilization


[00192896121607]

Dry Heat Sterilization


[00192896121607]

Dry Heat Sterilization


[00192896121607]

Dry Heat Sterilization


[00192896121607]

Dry Heat Sterilization


[00192896121607]

Dry Heat Sterilization


[00192896121607]

Dry Heat Sterilization


[00192896121607]

Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-16
Device Publish Date2025-06-06

On-Brand Devices [Micasept Top Dur Needle Holder]

00192896010925MICASEPT TOP DUR NEEDLE HOLDER WITH FOLDING RATCHET CURVED SHORT WIDE JAW
B09920918150MICASEPT TOP DUR NEEDLE HOLDER STRAIGHT WITH HEGAR RATCHET DOWN OPENING 30° CURVED DOWN
B09920918080MICASEPT TOP DUR NEEDLE HOLDER CURVED WITH HEGAR RATCHET CURVED SHORT WIDE JAW
B09920918070000MICASEPT TOP DUR DIRONDAL NEEDLE HOLDER STRAIGHT WITH HEGAR RATCHET SHORT WIDE JAW
B09920918050MICASEPT TOP DUR NEEDLE HOLDER STRAIGHT WITH HEGAR RATCHET STRAIGHT
00192896121607Micasept Top Dur Needle Holder With Hegar Ratchet Curved 4.5 Millimeter Tip

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.