SINGLE USE SPLINTING TUBE

SINGLE USE SPLINTING TUBE
SINGLE USE SPLINTING TUBE - ST-SB1

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 single-use device.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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

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

Device Id: 14953170237208

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04953170237201

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A

Device Id: 04953170237201

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: 24953170237205

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 14953170237208

Package Quantity: 10

Package Discontinue Date: 9/19/2023 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: N/A