TOTALSHIELD®

Basic Information

• Brand Name: TOTALSHIELD®
• Primary DI: 00889024376465
• Version / Model: 00-9900-312-10
• Catalog Number: 00-9900-312-10
• 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: 2017-11-07
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 110bd5a3-59ed-48bb-8713-dc4ab1f4fc49

Device Description

Zippered Surgical Toga, XL

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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	00889024380387	GS1	BOX	20	In Commercial Distribution
Primary	00889024376465	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			XL