MAJ-1222 PROTECTION TUBE FOR LTF-160

MAJ
PROTECTION TUBE - MAJ-1222

A tubular device intended to be used in combination with a compatible flexible endoscope to aid in endoscopic insertions and to secure a pathway for multiple endoscopic intubations during diagnostic and therapeutic endoscopic procedures (e.g., upper and/or lower gastrointestinal (GI) tract endoscopy). It is a non-steerable, typically single lumen tube constructed of plastic; some types may be "shape locked" into a desired configuration or form to assist in the repeated advancement and withdrawal of the endoscope (e.g., for the removal of multiple polyps and/or foreign bodies). This is a reusable device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Ethylene Oxide

Code: FDT

Device Name: Duodenoscope And Accessories, Flexible/Rigid

Device Class: 2

Physical State: endoscope, accessories associated with duodenoscope

Definition: To examine the duodenum and to perform various procedures within the duodenum. 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: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Inserted orally into duodenum

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: duodenum, esophagus

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Id: 04953170160028

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