K0509 CHOLE KIT

GUDID 20607915132013

Kit Contains: CTB03, 5x100 Kii SH BLD ZTHR 6/BX CTB33, 11X100 Kii SH BLD ZTHR 6/BX CA090, DIRECT DRIVE LCA 3/BX CB010, 5MMx34CM SCISSOR REPOS CRTR 10/BX C0R85, 12x100MM Kii BLT TIP SYS 6/BX

APPLIED MEDICAL RESOURCES CORPORATION

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Primary Device ID20607915132013
NIH Device Record Keyf9f80612-f094-4862-8a58-6a67ba646100
Commercial Distribution StatusIn Commercial Distribution
Brand NameK0509 CHOLE KIT
Version Model NumberGK323
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
GS120607915132013 [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 Number4
Public Version Date2020-01-09
Device Publish Date2015-10-09

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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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