TOTAL 5mm SOLUTION KIT 15

GUDID 20607915127729

Kit Contains: CFF03, 5x100 Kii Fios ADVFIX 6/BX CD003, 5mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BX CTS02, 5x100 Kii SLEEVE ZTHR 12/BX

APPLIED MEDICAL RESOURCES CORPORATION

Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag
Primary Device ID20607915127729
NIH Device Record Keyc31dcb70-0f44-4252-a3f8-8498de78618c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTOTAL 5mm SOLUTION KIT 15
Version Model NumberGK157
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
GS120607915127729 [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

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
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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