Sterimed

Basic Information

• Brand Name: Sterimed
• Primary DI: 00867878000439
• Version / Model: 0514
• Company Name: STERIMED LLC
• Labeler DUNS: 080284658
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-18
• Public Version: 3
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: 3d905f60-5b01-49a2-b032-8e8c8ced9610

Device Description

Bag 5” X 14” (0514)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IZI	System, X-Ray, Angiographic	Radiology	892.1600	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43071	X-ray system cover	A sterile piece of material used to cover an x-ray system during a surgical procedure to create a sterile barrier between the sterile operating field and the x-ray system, or the prominent parts of the x-ray system that intrude the sterile field. Since x-ray systems cannot be sterilized, this device is draped over/attached to the x-ray system allowing its use without compromising the sterile field. It will also protect the x-ray system from patient contaminants. It is available in a variety of shapes and sizes. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20867878000433	GS1	Case	8	In Commercial Distribution
Package	10867878000436	GS1	Inner Pack/Box	25	In Commercial Distribution
Primary	00867878000439	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K853044	000