SMARTSTITCH PERFECTPASSER SUTURE CARTRID
SMARTSTITCH PERFECTPASSER - OM-8178
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 IdentifiersDevice Id: 00817470005844
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: 20817470005848
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00817470005844
Package Quantity: 6
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BX