MAJ
OBCU REMOTE CONTROLLER - MAJ-1726
Device Description
A hand-operated electronic unit with a configuration of analogue or digital push-buttons (alphanumeric, colour-, or symbol-coded) designed to control the functions of an endoscopic device (e.g., endoscope video camera) from a distance via a connected cable or wirelessly [e.g., radio-frequency (RF), infrared (IR) transmission]. It is intended to be operated by the healthcare provider.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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: FED
Device Name: Endoscopic Access Overtube, Gastroenterology-Urology
Device Class: 2
Physical State: overtube
Definition: To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.
Submission Type ID: 1
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Endoscope inserted and advanced through center of device
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: various openings in gi and gu tract
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 Identifiers
Device Id: 04953170239564
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
