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 ID: 00842102104749
• NIH Device Record Key: 851cf4e3-ecff-4c86-9ad5-8ee0cb04ff19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The Cutting Edge System
• Version Model Number: 91385-45
• Catalog Number: 91385-45
• Company DUNS: 047644935
• Company Name: FLEXBAR MACHINE CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842102104749 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103840

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00842102104749]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-17

On-Brand Devices [The Cutting Edge System]

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