ENDER NAIL

Basic Information

• Brand Name: ENDER NAIL
• Primary DI: 00885556043530
• Version / Model: 71925258
• Catalog Number: 71925258
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-29
• Public Version: 5
• Public Version Date: 2023-09-29
• Public Version Status: Update
• Public Device Record Key: d24b8f68-a9e2-4e38-a3d9-fe055c026a1b
• Distribution End Date: 2023-09-28

Device Description

ENDER NAIL 2.5MM X 26CM

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: 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
JDS	NAIL, FIXATION, BONE	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38152	Tibia nail	A rod made of metal or other material intended to be implanted into the intramedullary canal of the tibia to immobilize the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. The device may be a locked or unlocked model and possess components to assist fixation of more proximal or distal conditions. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00885556043530	GS1

Customer Contacts

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