NA

Basic Information

• Brand Name: NA
• Primary DI: 05050474520707
• Version / Model: OM271000
• Catalog Number: OM271000
• Company Name: JOHNSON & JOHNSON SURGICAL VISION, INC.
• Labeler DUNS: 103021940
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-01
• Public Version: 4
• Public Version Date: 2024-01-25
• Public Version Status: Update
• Public Device Record Key: 8fad3012-31bd-41ec-8665-4369b9d42402
• Distribution End Date: 2023-01-01

Device Description

STERILE TRAY RING COVER SPECIFICATIONS

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: Yes
• 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
HQC	Unit, phacofragmentation	Ophthalmic	886.4670	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	15050474520704	GS1		48	Not in Commercial Distribution	2023-01-01
Primary	05050474520707	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K951462	000