Endo-shoulders

Basic Information

• Brand Name: Endo-shoulders
• Primary DI: 00885556674444
• Version / Model: E0015223-5
• Catalog Number: E0015223-5
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-09
• Public Version: 3
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: c024c582-568a-44ae-a1ac-103cbff6e639

Device Description

KOLBEL SMALL PADDLE

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAD	RETRACTOR	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35315	Orthopaedic retractor	A hand-held manual surgical instrument designed to separate and/or draw back tissues to permit access to skeletal structures for examination or intervention. It is made of high-grade stainless steel. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00885556674444	GS1

Customer Contacts

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