CHOLE KIT 6

GUDID 20607915130446

Kit Contains: CTR03, 5x100 Kii OPT ZTHR 6/BX CTS02, 5x100 Kii SLEEVE ZTHR 12/BX CTF33, 11x100 Kii Fios ZTHR 6/BX CTS12, 11x100 Kii SLEEVE ZTHR 12/BX CA090, DIRECT DRIVE LCA 3/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX

APPLIED MEDICAL RESOURCES CORPORATION

Spring-loaded pneumoperitoneum needle, single-use
Primary Device ID20607915130446
NIH Device Record Key2762cd04-3312-401d-b971-d1484bf8a8da
Commercial Distribution StatusIn Commercial Distribution
Brand NameCHOLE KIT 6
Version Model NumberGK311
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
GS120607915130446 [Primary]

FDA Product Code

HETLaparoscope, Gynecologic (And Accessories)

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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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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