KIT KE052 COLE/HASS

GUDID 20607915129334

Kit Contains: C0R47, 12x100 Kii BALLOON BLUNT TIP 6/BX CTF33, 11x100 Kii Fios ZTHR 6/BX CTF03, 5x100 Kii Fios Z-THR 6/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX CA090, DIRECT DRIVE LCA 3/BX

APPLIED MEDICAL RESOURCES CORPORATION

Laparoscopic irrigation/aspiration cannula
Primary Device ID20607915129334
NIH Device Record Keydc6a983c-7b52-4770-bc8b-05f782528e7b
Commercial Distribution StatusIn Commercial Distribution
Brand NameKIT KE052 COLE/HASS
Version Model NumberGK206
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
GS120607915129334 [Primary]

FDA Product Code

FHFSystem, Evacuator, Fluid

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

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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

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