SMARTSTITCH SUTURE CART.


Product Overview

SMARTSTITCH SUTURE CART.
SMARTSTITCH M-CONNECTOR - OM-8076


Device Description

A manually-operated, surgical device intended to be used in combination with a compatible arthroscope to mechanically approximate the edges of an internal wound or incision, including muscle tears, with sutures during arthroscopy. A suture punch mechanism places the number of sutures desired by the surgeon at the site of the lesion. This is a reusable device intended to be sterilized prior to use.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: GAT

Device Name: Suture, Nonabsorbable, Synthetic, Polyethylene

Device Class: 2

Physical State: N/A

Definition: N/A

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: Y

Target Area: N/A

Regulation Number: 878.5000

Third Party Flag: N

Medical Specialty: SU


Device Identifiers

Device Id: 20817470007415

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00817470007411

Package Quantity: 6

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: BX


Device Id: 00817470007411

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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