Kii® Optical Access System

GUDID 10607915116382

Trocars

APPLIED MEDICAL RESOURCES CORPORATION

Laparoscopic access cannula, single-use
Primary Device ID10607915116382
NIH Device Record Key3e7ef5c0-5ad3-48ef-85c4-6de297c0a5ff
Commercial Distribution Discontinuation2016-08-17
Commercial Distribution StatusNot in Commercial Distribution
Brand NameKii® Optical Access System
Version Model NumberC0R33
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 Latextrue
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
GS100607915116385 [Primary]
GS110607915116382 [Package]
Contains: 00607915116385
Package: [6 Units]
Discontinued: 2016-08-17
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 Number3
Public Version Date2020-01-09
Device Publish Date2016-08-17

On-Brand Devices [Kii® Optical Access System ]

10607915125056Trocar
10607915125049Trocar
10607915124844Laparoscopic Trocar Sleeve/Single Use
10607915124837Laparoscopic Trocar Sleeve/Single Use
10607915124240Trocar
10607915124233Laparoscopic Trocar Sleeve/Single Use
10607915124042Laparoscopic Trocar Sleeve/Single Use
10607915123960Laparoscopic Trocar Sleeve/Single Use
10607915123694Trocar
10607915123687Trocar
10607915123489Laparoscopic Trocar Sleeve/Single Use
10607915116665Trocars
10607915116641Trocars
10607915116634Trocars
10607915116443Trocars
10607915116436Trocars
10607915116429Trocars
10607915116412Trocars
10607915116382Trocars
10607915116375Trocars
10607915116344Trocars
10607915116337Trocars
10607915116306Trocars
10607915116290Trocars
10607915116283Trocars
10607915115927Trocars
10607915110038Laparoscopic Trocar Sleeve/Single Use
10607915110014Trocars

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