Camera sleeve

Basic Information

• Brand Name: Camera sleeve
• Primary DI: 15051223029202
• Version / Model: PS3901
• Catalog Number: PS3901
• Company Name: PURPLE SURGICAL INTERNATIONAL LIMITED
• Labeler DUNS: 239403863
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-16
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 765920e5-4993-45b2-830f-959c21fca7f8

Device Description

The camera sleeve is used to create a sterile field around the video system camera head and cable.

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: Yes
• 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
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	878.4160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37450	Camera cover, single-use	A sterile device made of a material, typically of plastic and shaped to fit the camera, which is used as a physical barrier on a camera to protect it from environmental exposure and/or allow the camera to be used in a sterile surgical field. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15051223029202	GS1
Package	35051223029206	GS1		20	In Commercial Distribution
Package	55051223029200	GS1		80	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			2.5m long x 100mm diameter