NA

Basic Information

• Brand Name: NA
• Primary DI: 10888551009935
• Version / Model: DEP8241-62-000
• Catalog Number: 8241-62-000
• Company Name: STERILMED, INC.
• Labeler DUNS: 175899459
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-18
• Public Version: 2
• Public Version Date: 2019-08-14
• Public Version Status: Update
• Public Device Record Key: dda906ee-1763-4887-a7a0-58daea907ebd

Device Description

TAP CANNULATED CANCELLOUS S-COUPLE

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: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HWX	TAP, BONE	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61802	Bone tap, reprocessed	A sterile, metal, surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end, and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached, whereby it will typically be manually rotated. This is a previously used single-use device that has been processed for an additional single-use patient application.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10888551009935	GS1

Customer Contacts

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