KIT KE095 COLE FIOS

GUDID 20607915129464

Kit Contains: CTF03, 5x100 Kii Fios Z-THR 6/BX CTF33, 11x100 Kii Fios ZTHR 6/BX CTS12, 11x100 Kii SLEEVE ZTHR 12/BX CA090, DIRECT DRIVE LCA 3/BX

APPLIED MEDICAL RESOURCES CORPORATION

Laparoscopic access cannula, single-use
Primary Device ID20607915129464
NIH Device Record Keyd53a4079-22f8-4294-8310-dc8465e85623
Commercial Distribution StatusIn Commercial Distribution
Brand NameKIT KE095 COLE FIOS
Version Model NumberGK219
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
GS120607915129464 [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

Devices Manufactured by APPLIED MEDICAL RESOURCES CORPORATION

00607915146467 - Voyant Electrosurgical Generator2026-01-26
00607915149024 - Inzii Ripstop Retrieval System2026-01-26
00607915140700 - Alexis® Orthopaedic Protector2025-04-16 X-S/M Flexible Alexis Orthopaedic Protector
00607915114688 - Threaded Cannula and Seal2024-12-16 Laparoscopic Trocar Sleeve
10607915140325 - Alexis® O Wound Protector-Retractor2024-09-04 Wound Retractor and Protector
10607915145528 - Inzii Ripstop Redeployable Retrieval System2024-03-27 Redeployable tissue retrieval system with Ripstop nylon bag.
00607915146498 - Suction Irrigation System2024-02-09 Probe and Valve with dual bag tubing.
00607915146504 - Suction Irrigation System2024-02-09 Valve with dual bag tubing.

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