The Cutting Edge System 91385-45

GUDID 00842102104749

Modular cutting edge handle w/insul shft, 5mm x 45cm

FLEXBAR MACHINE CORPORATION

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Primary Device ID00842102104749
NIH Device Record Key851cf4e3-ecff-4c86-9ad5-8ee0cb04ff19
Commercial Distribution StatusIn Commercial Distribution
Brand NameThe Cutting Edge System
Version Model Number91385-45
Catalog Number91385-45
Company DUNS047644935
Company NameFLEXBAR MACHINE CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100842102104749 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00842102104749]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-17

On-Brand Devices [The Cutting Edge System]

00842102105937Cutting Edge Relief Handle w/Insulated Shaft 5mm x 45cm
00842102105050Cutting Edge Relief Handle w/Insulated Shaft 5mm x 33cm
00842102105036CF Non-Ratcheted Hdl for Mod Scissor Tip Hdl
00842102104749Modular cutting edge handle w/insul shft, 5mm x 45cm
00842102104732Modular cutting edge handle, 5mm x 26cm
00842102104725Cutting Edge Handle w/Insulated Shaft and Ratchet 5mm x 33cm
00842102104718Modular cutting edge handle, 5mm x 33cm
00842102104701Cutting Edge Handle w/ Insulated Shaft and Ratchet 5mm x 33cm
00842102104695Medi-Clinch Grasper tip, single use
00842102104671Disposable Tip, Maryland Grasper, Sterile Pkg Single
00842102104657Disposable Tip, Hook Scissor, Sterile Pkg Single
00842102104633Disposable Tip, Mini Metz Scissor, Sterile Pkg Single
00842102104619Disposable Tip, Straight Scissor, Sterile Pkg Single
00842102104596Disposable Tip, Standard Wide Curved Metz, Sterile Pkg Single
00842102104565Disposable Tip, Curved Metz Scissor, Sterile Pkg Single
00842102104541Cutting Edge Handle w/ Insulated Shaft 5mm x 45cm
00842102104534Cutting Edge Handle w/ Insulated Shaft 5mm x 26cm
00842102104527Cutting Edge Handle w/Insulated Shaft, Ratchet 5mm x 45cm
00842102104510Cutting Edge Handle w/Insulated Shaft, Ratchet 5mm x 26cm
00842102104503Cutting Edge Handle w/Insulated Shaft, long post 5mm x 33cm
00842102104497Cutting Edge Handle w/ Insulated Shaft and long post,5mm x 45cm
00842102104480Cutting Edge Handle w/Insul. Shft & long post 5mm x 26cm
00842102104473Insulated Shaft for 45cm, Mod Scissor Tip Hdl
00842102104466Insert for 45cm Mod Scissor Tip Hdl
00842102104459Insulated Shaft for 26cm Mod Scissor Tip Hdl
00842102104442Insert for 26cm Mod Scissor Tip Hdl

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