SMARTSTITCH PERFECTPASSER

Basic Information

• Brand Name: SMARTSTITCH PERFECTPASSER
• Primary DI: 00817470001105
• Version / Model: OM-8177EA
• Catalog Number: OM-8177EA
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-21
• Public Version: 5
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: 8470493a-9044-48c9-8cb3-4ad4f60636bb

Device Description

SMARSTITCH PP MW BLACK COBRAID

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAT	SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE	General, Plastic Surgery	878.5000	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17735	Arthroscopic suturing unit	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817470001105	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K123268	000