PROFUNDA CLAMP

GUDID B0992100566D0

PROFUNDA DEBAKEY CLAMP SPOON JAW SHANK ANGLED BACKWARD

SONTEC INSTRUMENTS, INC.

Surgical soft-tissue manipulation forceps, scissors-like, reusable Surgical soft-tissue manipulation forceps, scissors-like, reusable Surgical soft-tissue manipulation forceps, scissors-like, reusable
Primary Device IDB0992100566D0
NIH Device Record Key9a1b1d6d-8e91-445e-808d-3e7bff51dfea
Commercial Distribution StatusIn Commercial Distribution
Brand NamePROFUNDA CLAMP
Version Model Number2100-566D
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

Length5.5 Inch
Length5.5 Inch
Length5.5 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896002647 [Primary]
HIBCCB0992100566D0 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXCClamp, Vascular

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B0992100566D0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0992100566D0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0992100566D0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-08-21
Device Publish Date2018-08-23

On-Brand Devices [PROFUNDA CLAMP]

B0992100566D0PROFUNDA DEBAKEY CLAMP SPOON JAW SHANK ANGLED BACKWARD
B09921005660PROFUNDA COOLEY CLAMP SPOON JAW/SHANK ANGLED BACKWARD

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