Flex

Basic Information

• Brand Name: Flex
• Primary DI: 00850190004698
• Version / Model: 50709PKG
• Company Name: MEDROBOTICS CORPORATION
• Labeler DUNS: 002764627
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-01
• Public Version: 4
• Public Version Date: 2020-05-12
• Public Version Status: Update
• Public Device Record Key: cb5fa08c-af78-4f01-a1c9-015cfbaf27e8

Device Description

Hypercurved Laryngeal Blade, 120-150mm x 36mm Wide

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KAL	Retractor, Ent	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63117	Robotic surgical retractor	A surgical device intended to be used in conjunction with a robotic surgical system to enable retraction of tissues during a robotic endoscopic procedure. It is designed as a long shaft with a distal retracting mechanism (e.g., fan-like opening blades), and a proximal housing intended to be connected directly to an arm of the robotic surgical system. It is not intended for surgical wound retraction or tissue cutting. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850190004698	GS1