ELITE

Basic Information

• Brand Name: ELITE
• Primary DI: 03596010512291
• Version / Model: 7210693
• Catalog Number: 7210693
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-21
• Public Version: 4
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: c82f75b5-0b3c-4fc4-bb1b-ebe74d751c00
• Distribution End Date: 2017-08-08

Device Description

SUTURE NEEDLE SHUTTLE STERILE

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61143	Suturing needle, single-use	A cylindrical-shaped, solid, metal instrument intended to be used to insert and pull suture material through tissue (e.g., skin, fascia, serous, vascular, or other tissue/organ) during surgical stitching of tissues. It is available in various lengths, curvatures, diameters, cross-sectional shapes, and distal end forms. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	23596010512295	GS1	BX	5	Not in Commercial Distribution	2017-08-08
Primary	03596010512291	GS1

Customer Contacts

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