REFERENCE PLATE COVER

REFERENCE PLATE COVER
REFERENCE PLATE COVER - MAJ-1880

A device designed to hold (house) a sensor so that it is fixed (locked) in a stable position, including adhesive fixation. It will then allow for the holder and the attached sensor to be fastened to, e.g., the patient's body, another device, or a suitable place in the vicinity of use. This is a single-use device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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: FDA

Device Name: Enteroscope And Accessories

Device Class: 2

Physical State: enteroscope and related accessories, may include balloon, mini-scope

Definition: To provide visualization and perform various procedures within the small intestine. 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 through mouth or laparoscopically

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: small intestine

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Code: PGU

Device Name: Spatial Imaging For Display Of Endoscope Position

Device Class: 2

Physical State: A control unit that communicates with an endoscope/accessory probe, a receiver dish, and display monitor.

Definition: To detect and display the shape of an inserted endoscope.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Measures electromagnetic fields from the endoscope or an accessory within an endoscope to determine the shape of an inserted endoscope, and displays it on a monitor.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Gastrointestinal system

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Id: 04953170305719

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: 84953170305715

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