TOTALSHIELD®

Basic Information

• Brand Name: TOTALSHIELD®
• Primary DI: 00889024378438
• Version / Model: 89-9901-000-00
• Catalog Number: 89-9901-000-00
• Company Name: ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
• Labeler DUNS: 137354267
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 3
• Public Version Date: 2021-08-24
• Public Version Status: Update
• Public Device Record Key: ce08d7e6-68b4-4747-b377-9d592f4a0440

Device Description

TOTALSHIELD EVALUATION KIT

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: No
• 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: High-level Disinfectant

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FYA	GOWN, SURGICAL	General, Plastic Surgery	878.4040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35102	Surgical helmet system	A system intended for the purpose of protecting healthcare workers and patients from cross-infection during surgery. It is typically composed of a helmet frame with a face shield, a loose fitting disposable hood or gown draped around this, inflow and exhaust fans and filters, and a power supply, e.g., a battery pack to drive the internal ventilation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00889024378438	GS1

Customer Contacts

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