Biopsy valve

Biopsy valve - MB-358

A device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. It is typically in the form of a small attachment with an elastomer seal; it may include features to allow for simultaneous irrigation/biopsy, or to allow suction via the biopsy port. 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: FDS

Device Name: Gastroscope And Accessories, Flexible/Rigid

Device Class: 2

Physical State: endoscope, accessories associated with gastroscope

Definition: To examine or perform procedures in the stomach. 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: Inserted orally into the stomach

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: stomach

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Code: FDF

Device Name: Colonoscope And Accessories, Flexible/Rigid

Device Class: 2

Physical State: endoscope, accessories associated with colonoscope

Definition: To examine or perform procedures in the colon or rectum 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: Inserted into anus

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: colon or rectum

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Code: NWB

Device Name: Endoscope, Accessories, Narrow Band Spectrum

Device Class: 2

Physical State: The system consists of flexible and/or ridgid scope(s), light source(s), video processor and display

Definition: Alternative mode of visualization using narrow bands from the visible spectrum for illumination and indicated for endoscopy and endoscopic surgery of the upper and lower diagestive tract and urinary tract.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Enhances visualization of specific structures and reduces obscuring effects by using narrow bands of the visible spectrum for illumination. Narrow band illumination is accomplished through the modification of broadband light sources with optical filters or using light sources with inherently limited spectra such as lasers

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Limited to endoscopic systems for observation of the gastro-urological tract

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Id: 84953170063943

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

Device Id: 04953170438165

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