Endoloop Applicator

Endoloop Applicator
NA - 0250080701

A manually-operated device intended to be used in combination with a compatible flexible endoscope (e.g., gastroscope, laparoscope) to mechanically approximate the edges of an internal wound or incision with sutures, typically during a gastrointestinal (GI) procedure. It is typically loaded with a needle/suture assembly and attached to the working end, or inserted through the working channel, of the endoscope. The device will also knot and cut the sutures as they are stitched; some types may also carry and/or knot a ligature. This is a reusable device intended to be sterilized prior to use.

No Data Available

• Outer Diameter: 5.0 Millimeter

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Moist Heat or Steam Sterilization

Code: OCZ

Device Name: Endoscopic Grasping/Cutting Instrument, Non-Powered

Device Class: 2

Physical State: Non-electric and non-magnetic devices. May include: grasping or retrieval forceps, biopsy forceps or other sampling tools, scissors, stone basket, stone dislodger

Definition: To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Place through an endoscope to reach desired area.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: various tissues, stones or other foreign bodies within GI and GU tract.

Regulation Number: 876.1500

Third Party Flag: Y

Medical Specialty: GU

Device Id: 07613327058666

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