CALCANEA™

Basic Information

• Brand Name: CALCANEA™
• Primary DI: 10381780051954
• Version / Model: 129139ND
• Company Name: NEWDEAL
• Labeler DUNS: 536935331
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-26
• Public Version: 3
• Public Version Date: 2018-04-03
• Public Version Status: Update
• Public Device Record Key: 3967e551-3a6a-42f8-a42c-b9030a914824
• Distribution End Date: 2018-02-28

Device Description

The right bender is used to shape the plate according to the bone configuration, together with the left bender referenced 129140ND.

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: Yes
• 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: Yes
• 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
HXW	BENDER	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44795	Manual orthopaedic bender, reusable	A manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. The bending process is typically performed within the operating room (OR), inside or outside of the operative sterile field. The device may be hand held or table mounted. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M248129139ND1	HIBCC
Primary	10381780051954	GS1

Customer Contacts

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