MICASEPT TOP DUR DIRONDAL NEEDLE HOLDER 20918-08-302

GUDID 00192896007956

MICASEPT TOP DUR DIRONDAL NEEDLE HOLDER WITH HEGAR RATCHET CURVED TIP WIDE JAW

SONTEC INSTRUMENTS, INC.

Needle holder, reusable
Primary Device ID00192896007956
NIH Device Record Keyeac298bd-725f-45f7-a95d-372a29bc443d
Commercial Distribution StatusIn Commercial Distribution
Brand NameMICASEPT TOP DUR DIRONDAL NEEDLE HOLDER
Version Model Number20918-08-302
Catalog Number20918-08-302
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

Length11 Inch
Length11 Inch
Length11 Inch
Length11 Inch
Length11 Inch
Length11 Inch
Length11 Inch
Length11 Inch
Length11 Inch
Length11 Inch
Length11 Inch
Length11 Inch
Length11 Inch
Length11 Inch
Length11 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896007956 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00192896007956]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896007956]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896007956]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896007956]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896007956]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896007956]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896007956]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896007956]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896007956]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896007956]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896007956]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896007956]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896007956]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896007956]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896007956]

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 [MICASEPT TOP DUR DIRONDAL NEEDLE HOLDER]

00192896007963MICASEPT TOP DUR DIRONDAL NEEDLE HOLDER WITH HEGAR RATCHET CURVED TIP WIDE JAW
00192896007956MICASEPT TOP DUR DIRONDAL NEEDLE HOLDER WITH HEGAR RATCHET CURVED TIP WIDE JAW
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