Drape

Basic Information

• Brand Name: Drape
• Primary DI: 10841436120873
• Version / Model: 610-2381
• Catalog Number: 610-2381
• Company Name: CIVCO MEDICAL INSTRUMENTS CO., INC.
• Labeler DUNS: 134614411
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-21
• Public Version: 1
• Public Version Date: 2021-01-29
• Public Version Status: New
• Public Device Record Key: b5203651-b8d1-45d8-a83d-ba9206b4960a

Device Description

Non-sterile (50.8x71.1cm) polyethlene drape

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ITX	Transducer, ultrasonic, diagnostic	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12535	Medical equipment drape, single-use	A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00841436120876	GS1		24	In Commercial Distribution
Primary	10841436120873	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K970513	000

Device Sizes

Type	Value	Unit	Text
Length	50.8	Centimeter
Width	71.1	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Away from Sunlight