Ascension®

Basic Information

• Brand Name: Ascension®
• Primary DI: 10381780242307
• Version / Model: BRH10105P
• Catalog Number: BRH-101-05P
• Company Name: Ascension Orthopedics, Inc.
• Labeler DUNS: 942377524
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-30
• Public Version: 4
• Public Version Date: 2023-01-25
• Public Version Status: Update
• Public Device Record Key: 80435436-1ac1-4ddf-b826-ea8bdbe9ec6d
• Distribution End Date: 2026-12-31

Device Description

MCP Proximal Cutting Broach Sz. 05

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: Yes
• 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
HTQ	BROACH	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36167	Orthopaedic broach	A surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M269BRH10105P1	HIBCC
Primary	10381780242307	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Size 05