K0588 Kit

GUDID 20607915129167

Kit Contains: CTF33, 11x100 Kii Fios ZTHR 6/BX CTR12, 5x100 Kii OPT ZTHR DP 10/BX CTS12, 11x100 Kii SLEEVE ZTHR 12/BX CA090, DIRECT DRIVE LCA 3/BX

APPLIED MEDICAL RESOURCES CORPORATION

Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use Laparoscopic access cannula, single-use
Primary Device ID20607915129167
NIH Device Record Key37dd2ce6-d7fc-4462-a089-329724a1fe39
Commercial Distribution StatusIn Commercial Distribution
Brand NameK0588 Kit
Version Model NumberGK204
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 Kittrue
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
Phone1.949.713.8300
Emailcontact@appliedmedical.com
Phone1.949.713.8300
Emailcontact@appliedmedical.com
Phone1.949.713.8300
Emailcontact@appliedmedical.com
Phone1.949.713.8300
Emailcontact@appliedmedical.com
Phone1.949.713.8300
Emailcontact@appliedmedical.com
Phone1.949.713.8300
Emailcontact@appliedmedical.com
Phone1.949.713.8300
Emailcontact@appliedmedical.com
Phone1.949.713.8300
Emailcontact@appliedmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS120607915129167 [Primary]

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 Date2015-10-09

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00607915140809 - Voyant Maryland Fusion Device with Single-Step Activation2023-04-04 Voyant Maryland Fusion Device with Single-Step Activation
10607915140813 - Voyant Maryland Fusion Device with Single-Step Activation2023-04-04 Electrosurgical Sealer and Divider handpiece
10607915145313 - GelPOINT V-Path 2023-03-27 Transvaginal Access Platform with Insufflation Stabilization System
10607915145320 - GelPOINT V-Path 2023-03-27 Transvaginal Access Platform with Insufflation Stabilization System

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