Direct Drive Laparoscopic Grasping System

GUDID 00607915116972

Reusable Grasper Handle

APPLIED MEDICAL RESOURCES CORPORATION

Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable
Primary Device ID00607915116972
NIH Device Record Key89a14f10-a58a-42db-b567-7f08e2041357
Commercial Distribution StatusIn Commercial Distribution
Brand NameDirect Drive Laparoscopic Grasping System
Version Model NumberC5223
Company DUNS187129135
Company NameAPPLIED MEDICAL RESOURCES CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100607915116972 [Primary]

FDA Product Code

NWVLaparoscopic Accessories, Gynecologic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00607915116972]

Moist Heat or Steam Sterilization


[00607915116972]

Moist Heat or Steam Sterilization


[00607915116972]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-08-21
Device Publish Date2016-09-24

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