TOTALSHIELD®

Basic Information

• Brand Name: TOTALSHIELD®
• Primary DI: 00889024376267
• Version / Model: 00-9900-004-00
• Catalog Number: 00-9900-004-00
• Company Name: Zimmer, Inc.
• Labeler DUNS: 056038268
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-07
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 5222f767-5b86-4abd-9779-1ff63f050b3c

Device Description

Headband Memory Foam Pads

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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

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
Package	00889024380349	GS1	BOX	8	In Commercial Distribution
Primary	00889024376267	GS1

Customer Contacts

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