Sterimed

Basic Information

• Brand Name: Sterimed
• Primary DI: 00850341007110
• Version / Model: 0586L-R
• 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: 00150095-7902-4b91-84ca-4437dbd24e23

Device Description

Extra Long C-Arm Cover W/O Bands 53" X 106"

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
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	20850341007114	GS1	Case	4	In Commercial Distribution
Package	10850341007117	GS1	Inner Pack/Box	20	In Commercial Distribution
Primary	00850341007110	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K853044	000