LAP CHOLE KIT 15 GK

GUDID 20607915120911

Kit Contains: CA090, DIRECT DRIVE LCA 3/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CTS02, 5x100 Kii SLEEVE ZTHR 12/BX CTB33, 11X100 Kii SH BLD ZTHR 6/BX CTB12, 5x100 Kii SH BLD ZTHR DP 10/BX

APPLIED MEDICAL RESOURCES CORPORATION

Laparoscopic access cannula, single-use
Primary Device ID20607915120911
NIH Device Record Key38c16611-6d66-4e7a-b41a-fa5739471087
Commercial Distribution Discontinuation2018-09-12
Commercial Distribution StatusNot in Commercial Distribution
Brand NameLAP CHOLE KIT 15 GK
Version Model NumberGK115
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
GS120607915120911 [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 Number4
Public Version Date2020-01-09
Device Publish Date2015-10-09

Devices Manufactured by APPLIED MEDICAL RESOURCES CORPORATION

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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.
10607915140790 - Voyant Maryland Fusion Device with Single-Step Activation2023-04-04 Electrosurgical Sealer and Divider handpiece
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

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