Cylinder Standard

Cylinder Standard
Otopore - 5400010000

A fragmentable packing, composed of a biodegradable material [e.g., poly(DL-lactide-co-caprolactone)], intended to prevent adhesions between mucosal surfaces in the ear of a patient undergoing outer ear surgery. It typically helps to mimimize bleeding via a tamponade effect and blood absorption. This is a single-use device.

• Length: 10.0 Millimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NHB

Device Name: Polymer, Ear, Nose And Throat, Synthetic, Absorbable

Device Class: 2

Physical State: N/A

Definition: Ear, nose, and throat absorbable synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is shaped and formed by the surgeon to conform to the patient's needs. This generic type of device is made of absorbable synthetic polymer materials.

Submission Type ID: 1

Review Panel: EN

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: 874.3620

Third Party Flag: N

Medical Specialty: EN

Device Id: 37613327301664

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 07613327301663

Package Quantity: 8

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: pack

Device Id: 07613327301663

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