MOGEN CIRCUMCISION CLAMP

GUDID B0995403740

MOGEN CIRCUMCISION CLAMP

SONTEC INSTRUMENTS, INC.

Surgical penis clamp, reusable
Primary Device IDB0995403740
NIH Device Record Key622c7333-7245-4ffd-8987-136a844164fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameMOGEN CIRCUMCISION CLAMP
Version Model Number540-374
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

Length3 Inch
Length3 Inch
Length3 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896001558 [Primary]
HIBCCB0995403740 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HFXClamp, Circumcision

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B0995403740]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B0995403740]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B0995403740]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-24
Device Publish Date2018-08-22

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