Optical Separator® System

GUDID 10607915114104

Optical Separator Trocar

APPLIED MEDICAL RESOURCES CORPORATION

Laparoscopic access cannula, single-use
Primary Device ID10607915114104
NIH Device Record Key8999718c-042e-4ff4-a4ed-eb3b01682b03
Commercial Distribution Discontinuation2018-11-06
Commercial Distribution StatusNot in Commercial Distribution
Brand NameOptical Separator® System
Version Model NumberC0128
Company DUNS187129135
Company NameAPPLIED MEDICAL RESOURCES CORPORATION
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1.949.713.8300
Emailcontact@appliedmedical.com
Phone1.949.713.8300
Emailcontact@appliedmedical.com
Phone1.949.713.8300
Emailcontact@appliedmedical.com

Device Dimensions

Lumen/Inner Diameter12 Millimeter
Lumen/Inner Diameter12 Millimeter
Lumen/Inner Diameter12 Millimeter
Lumen/Inner Diameter12 Millimeter
Length100 Millimeter
Lumen/Inner Diameter12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100607915114107 [Primary]
GS110607915114104 [Package]
Contains: 00607915114107
Package: [6 Units]
Discontinued: 2018-11-06
Not in Commercial Distribution

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-09
Device Publish Date2016-08-30

On-Brand Devices [Optical Separator® System]

10607915115378Laparoscopic Trocar
10607915114111Optical Separator Trocar
10607915114104Optical Separator Trocar
10607915114067Optical Separator Trocar
10607915114050Optical Separator Trocar
10607915114043Optical Separator Trocar
10607915114029Optical Separator Trocar

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.