Sterimed

Basic Information

• Brand Name: Sterimed
• Primary DI: 00850341007622
• Version / Model: 4480SB
• Company Name: STERIMED LLC
• Labeler DUNS: 080284658
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 3
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: 47552ad1-b0f0-4c2e-9b74-3a934975fc7f

Device Description

C-Arm Cover with Straps 44" X 80", Non-sterile

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: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Radiation Sterilization", "Ethylene Oxide"]

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
45640	C-arm drape	A sterile device intended to cover/wrap the C-arm and/or mini C-arm of a mobile or stationary fluoroscopic x-ray system and function as a physical barrier to prevent cross-contamination between the C-arm and the surgical staff/field during a procedure. It is typically made of flexible plastic and shaped to fit the C-arm; it is available in various 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	10850341007629	GS1	Case	100	In Commercial Distribution
Primary	00850341007622	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K853044	000