GOMCO CIRCUMCISION CLAMP

GUDID B099540392B0

BLACK GOMCO CIRCUMCISION CLAMP

SONTEC INSTRUMENTS, INC.

Surgical penis clamp, reusable
Primary Device IDB099540392B0
NIH Device Record Keyb00b60e0-45c0-4315-9377-1c77147a3464
Commercial Distribution StatusIn Commercial Distribution
Brand NameGOMCO CIRCUMCISION CLAMP
Version Model Number540-392B
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

Lumen/Inner Diameter13 Millimeter
Lumen/Inner Diameter13 Millimeter
Lumen/Inner Diameter13 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896001619 [Primary]
HIBCCB099540392B0 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HFXClamp, Circumcision

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B099540392B0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B099540392B0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B099540392B0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


Device Entry Metadata

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

On-Brand Devices [GOMCO CIRCUMCISION CLAMP ]

B0995403960GOMCO CIRCUMCISION CLAMP CHROME
B099540394B0BLK GOMCO CIRCUMCISION CLAMP
B0995403940GOMCO CIRCUMCISION CLAMP CHROME
B099540392B0BLACK GOMCO CIRCUMCISION CLAMP
B0995403920GOMCO CIRCUMCISION CLAMP CHROME
B099540390B0BLACK GOMCO CIRCUMCISION CLAMP CHROME
B099540388B0BLACK GOMCO CIRCUMCISION CLAMP
B099540396B0BLACK GOMCO CIRCUMCISION CLAMP
B0995403890GOMCO CIRCUMCISION CLAMP CHROME

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