- Physicians Office Resource

Suture Ligature with Delivery System,SK
Surgiwip - ELW-52

Device Description

A device that is used to constrict a protruding tissue, e.g., a varix or a polyp to prevent or control bleeding following, e.g., a polypectomy, thereby creating a haemostasis or necrosis during an endoscopic procedure. It is applied using a dedicated endoscopic ligator. This is a single-use device.

Environmental Conditions

Handling Environment Temperature - Degrees Fahrenheit

130.00
N/A

Device Sizes

diameter,0,N/A;

diameter,0,N/A;

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: GCJ

Device Name: Laparoscope, General & Plastic Surgery

Device Class: 2

Physical State: N/A

Definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 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: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Identifiers

Device Id: 20884521132105

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10884521132108

Package Quantity: 6

Package Discontinue Date: 10/2/2019 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: CASE

Device Id: 10884521132108

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

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