V.A.T.S. SLIDER HARKEN DEBAKEY CLAMP

GUDID B09921008211R0

V.A.T.S. SLIDER HARKEN DEBAKEY CLAMP WITH RATCHET STRONG CURVED

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 IDB09921008211R0
NIH Device Record Key97b8197a-db9f-47e7-8876-e6348c764ba1
Commercial Distribution StatusIn Commercial Distribution
Brand NameV.A.T.S. SLIDER HARKEN DEBAKEY CLAMP
Version Model Number2100-8211R
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

Phone303-790-9411
Emailinfo@sontecinstruments.com
Phone303-790-9411
Emailinfo@sontecinstruments.com
Phone303-790-9411
Emailinfo@sontecinstruments.com

Device Dimensions

Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch
Length14 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896003583 [Primary]
HIBCCB09921008211R0 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B09921008211R0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B09921008211R0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B09921008211R0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-08-21
Device Publish Date2018-08-28

On-Brand Devices [V.A.T.S. SLIDER HARKEN DEBAKEY CLAMP]

B09921008211R0V.A.T.S. SLIDER HARKEN DEBAKEY CLAMP WITH RATCHET STRONG CURVED
00192896115521V.A.T.S. Slider Harken Debakey Clamp Without Ratchet Strong Curve 1x2 Teeth

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