SUCTION VALVE MAJ
SUCTION VALVE - MAJ-207
Device Description
A device intended to be fitted to an endoscope suction channel to enable the operator to control suction whist preventing inflow of air. It is in the form of an attachable valve that controls (opens/closes) the suction channel. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- Ethylene Oxide
- High-level Disinfectant
- Moist Heat or Steam Sterilization
Product Codes
Code: KGE
Device Name: Forceps, Biopsy, Electric
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: GU
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: 876.4300
Third Party Flag: Y
Medical Specialty: GU
Code: FGA
Device Name: Kit, Nephroscope
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: GU
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: 876.1500
Third Party Flag: N
Medical Specialty: GU
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
Code: KNS
Device Name: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: GU
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: 876.4300
Third Party Flag: Y
Medical Specialty: GU
Device IdentifiersDevice Id: 04953170063428
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
Device Id: 84953170063424
Device Type: Unit of Use
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