"MB-326 EYECUP F/OES FIBERSCOPE"

"MB
OES EYEPIECE HOOD - MB-326

A soft contouring device intended to be attached to the eyepiece of a medical scope (e.g., endoscope, ophthalmoscope, microscope) to provide comfort for, or assist positioning of, the eye during use of the scope; it is not a storage cover. It may be in the form of a covering, brow rest, or eyecup and is typically intended for contact with a healthcare professional while performing a procedure, but some types are intended for contact with the patient while being viewed with an opthalmoscope; it does not include optics. This is a reusable device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Ethylene Oxide

Code: EOQ

Device Name: Bronchoscope (Flexible Or Rigid)

Device Class: 2

Physical State: N/A

Definition: A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Submission Type ID: 1

Review Panel: EN

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 874.4680

Third Party Flag: N

Medical Specialty: EN

Device Id: 04953170063954

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A