MAJ-1413 LGHT GDE ADAP LF-DP/GP/TP,CYF-5

MAJ
Light Guide Adapter - MAJ-1413

A device that provides an optical interface to match the light characteristics from an external light source (from a different endoscope manufacturer or model) to the fibreoptic bundles of an endoscope. This is a reusable device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• High-level Disinfectant
• Ethylene Oxide

Code: FAJ

Device Name: Cystoscope And Accessories, Flexible/Rigid

Device Class: 2

Physical State: endoscope, accessories associated with cystoscope

Definition: To examine and perform procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data 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: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Intrument guided through urethra for visualization and to perform various procedures.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: bladder, urethra, kidneys

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Id: 04953170180767

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