Integra®

Basic Information

• Brand Name: Integra®
• Primary DI: 10381780247630
• Version / Model: TMP40020
• Catalog Number: TMP-400-20
• Company Name: Ascension Orthopedics, Inc.
• Labeler DUNS: 942377524
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-02
• Public Version: 5
• Public Version Date: 2023-01-25
• Public Version Status: Update
• Public Device Record Key: 3146bc95-81e5-4d3e-b28c-ce042e917760
• Distribution End Date: 2026-12-31

Device Description

Surgical Instruments; Sizing Template, PHS Sz. 20; Sizing Template used to assess coverage and establish sizing for a component.

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
HWT	TEMPLATE	Orthopedic	888.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46479	Surgical implant template, reusable	A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M269TMP400201	HIBCC
Primary	10381780247630	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Size 20; .436 in dia head